510(k) K153540 ยท FRG Wrap, Sterilization
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
| Applicant | Safe Secure Packaging Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Aug 4, 2016 |
| Received | Dec 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153540
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881031 Terminated |
FRG | None listed |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs
Model Number: 881041 Terminated |
FRG | None listed |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs
Model Number: 881061 Terminated |
FRG | None listed |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs
Model Number: 881091 Terminated |
FRG | None listed |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case
Model Number: 883411 Terminated |
FRG | None listed |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case
Model Number: 883610 Terminated |
FRG | None listed |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case
Model Number: 883713 Terminated |
FRG | None listed |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case
Model Number: 884039 Terminated |
FRG | None listed |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case
Model Number: 884118 Terminated |
FRG | None listed |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case
Model Number: 884411 Terminated |
FRG | None listed |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case
Model Number: 884510 Terminated |
FRG | None listed |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case
Model Number: 884515 Terminated |
FRG | None listed |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case
Model Number: 884713 Terminated |
FRG | None listed |
| Dec 2, 2020 | Steris Corporation Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case
Model Number: 884816 Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enc Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10 rolls/cs
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare provider Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 boxes per case 6 rolls/cs
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare provider Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclos Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclos Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to encl Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to encl Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to encl Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to encl Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enc Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enc Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclo Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclo Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to en Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclo Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclo Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to encl Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to encl Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to encl Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to encl Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to en Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enc Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclo Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enc Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclo Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enc Terminated |
FRG | None listed |
| Jun 15, 2017 | Steris Corporation Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclo Terminated |
FRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.