Identity
- Trade Name
- Medichoice FDA UDI
- Generic Name
- Wound closure set, topical FDA UDI
- Device Name
- Tray Laceration 4X4In 8Ply Gauze 18X26In Fenestrated Drape 17X19In Drape Iris Scissor Straight 4.5In Adson Tissue Forcep 4.75In 1X2 Teeth Iris Forcep Straight 4In 1X2 Teeth Mosquito Halstead Curved 5In Webster Needle Holder Smooth 5In Med Cup 2 Oz. 6In Ct FDA UDI
- Model / Reference
- LAC1002 FDA UDI
- Description
- Tray Laceration 4X4In 8Ply Gauze 18X26In Fenestrated Drape 17X19In Drape Iris Scissor Straight 4.5In Adson Tissue Forcep 4.75In 1X2 Teeth Iris Forcep Straight 4In 1X2 Teeth Mosquito Halstead Curved 5In Webster Needle Holder Smooth 5In Med Cup 2 Oz. 6In Ct FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10885632114311 FDA UDI
- FDA Product Code
- OVN FDA UDI
- GMDN Term
- Wound closure set, topical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4830 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wound closure set, topical
Medichoice by Owens & Minor Distribution, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Trinity Sterile, Inc. — TRINITY STERILE, INC. · Class I
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- DERMABOND PRINEO — Ethicon Inc. · Class II
- DERMABOND PRINEO — Ethicon Inc. · Class II
- Trinity Sterile, Inc. — TRINITY STERILE, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI d4dea3d7-a237-432a-b191-47b8a7e17855 34 fields · synced May 30, 2026