Company
Trinity Sterile, Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OXQ | Dressing Change Tray | 10 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2025 | Trinity Sterile, Inc. Brand Name: Tacy Medical, Inc.
Product Name: Dressing Change Tray CS/20
Model/Catalog Number: TM6180CP
Software Version: N/A
Product Description: Dressing change tray, case of 20, lot #600032, 50 case Open, Classified |
OXQ | None listed |
| Jan 22, 2025 | Trinity Sterile, Inc. Brand Name: Wolf-Pak
Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30
Model/Catalog Number: DC5090LF
Software Version: N/A
Product Description: Dressing change kit, case of 30, Open, Classified |
OXQ | None listed |
| Jan 22, 2025 | Trinity Sterile, Inc. Brand Name: Wolf-Pak
Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30
Model/Catalog Number: DC3080LF
Software Version: N/A
Product Description: Open, Classified |
OXQ | None listed |
| Jan 22, 2025 | Trinity Sterile, Inc. Brand Name: Wolf-Pak
Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30
Model/Catalog Number: DC3077LF
Software Version: N/A
Product Description: Dressing Open, Classified |
OXQ | None listed |
| Jan 22, 2025 | Trinity Sterile, Inc. Brand Name: IMed Products
Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD
Model/Catalog Number: IM46062
Software Version: N/A
Product Description: Dressing change kit, case of 30, lo Open, Classified |
OXQ | None listed |
| Jun 29, 2022 | Trinity Sterile, Inc. Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30
Ref: DC5090LF Terminated |
OXQ | None listed |
| Jun 29, 2022 | Trinity Sterile, Inc. Wolf Pak Premium Dressing Change Kit with Statlock CS/30
Ref: DC5040LF Terminated |
OXQ | None listed |
| Jun 29, 2022 | Trinity Sterile, Inc. Wolf-Pak Premium Dressing Kit with GuardVA Cs/30
Ref: DC5030LF Terminated |
OXQ | None listed |
| Jun 29, 2022 | Trinity Sterile, Inc. Sklar Instruments IV Cath Dressing Tray Cs/25
Re-Order Number: 96-1708 Terminated |
OXQ | None listed |
| Feb 23, 2021 | Trinity Sterile, Inc. Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing).
Product Number: TRIO0000l Terminated |
OXQ | None listed |