ClearanceBrief
Panels › General, Plastic Surgery › Product code OJU · Class 1

Skin Prep Tray

Regulation 878.4800

0510(k)s in 12 months (1 all time)
4recalls in 12 months (21 all time)
0recalls that name a 510(k)
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Top companies in OJU

DateFirm and productCodeLinked 510(k)
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM1398B
Open, Classified
OJUNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number: DYKS1128C; 3) PRE OP KIT, Catalog Number: DYKS1216I; 4) PRE OP KIT, Catalog Number: DYKS1325A; 5)
Open, Classified
OJUNone listed
Apr 30, 2026Medline Industries, LP
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
Open, Classified
OJUNone listed
Jan 12, 2026Medline Industries, LP
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT,
Open, Classified
OJUNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
Open, Classified
OJUNone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2499; 3) ED PREP TRAY, Pack Number DYNDA2519; 4) ED PREP TRAY, Pack Number DYNDA2
Open, Classified
OJUNone listed
Aug 28, 2024MEDLINE INDUSTRIES, LP - Northfield
Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250
Open, Classified
OJUNone listed
Mar 29, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
Open, Classified
OJUNone listed
Feb 25, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, REF DYKS1377A
Open, Classified
OJUNone listed
Feb 10, 2023MEDLINE INDUSTRIES, LP - Northfield
Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A
Open, Classified
OJUNone listed
Jun 6, 2022MEDLINE INDUSTRIES, LP - SPT
Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131
Open, Classified
OJUNone listed
Apr 13, 2020American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Terminated
OJUNone listed
Feb 10, 2020Medline Industries Inc
Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022.
Terminated
OJUNone listed
Feb 10, 2020Medline Industries Inc
Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
Terminated
OJUNone listed
Dec 11, 2019Centurion Medical Products Corporation
Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP415 STERILE GAUZE SPONGE
Terminated
OJUNone listed
Dec 11, 2019Centurion Medical Products Corporation
Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY
Terminated
OJUNone listed
Dec 11, 2019Centurion Medical Products Corporation
Centurion-Skin Prep Tray DYNDP1015 SKIN PREP TRAY
Terminated
OJUNone listed
Jun 6, 2013American Optisurgical Inc
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Terminated
OJUNone listed
Mar 26, 2013CareFusion 213, LLC
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
Terminated
OJUNone listed
Mar 14, 2012Carefusion 2200 Inc
Wet PVP-I Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder
Terminated
OJUNone listed
Mar 14, 2012Carefusion 2200 Inc
Wet PVP-I Small Procedure Preoperative Skin Prep Tray containing 1 - 59 mL bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 59 mL bottle Povidone Iodine Topical Solution (Paint) USP
Terminated
OJUNone listed

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