Identity
- Trade Name
- UNIPRO FDA UDI
- Generic Name
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
- Device Name
- Monofilament Polypropylene Synthetic non-absorbable Surgical Sututres / Ligatures FDA UDI
- Model / Reference
- DW9443 FDA UDI
- Description
- Monofilament Polypropylene Synthetic non-absorbable Surgical Sututres / Ligatures FDA UDI
Identifiers
- Catalog Number
- DW9443 FDA UDI
- Primary DI / UDI-DI
- 16285379148862 FDA UDI
- 510(k) Number
- K042283 FDA UDI
- FDA Product Code
- GAW FDA UDI
- GMDN Term
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.3 Millimeter FDA UDI
Category: Polyolefin/fluoropolymer suture, monofilament
Unipro by United Medical Industries Co. Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyolefin/fluoropolymer suture, monofilament.
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- DemeLENE — DemeTECH Corp · Class II
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- Premilene — B BRAUN SURGICAL SA · Class II
- DEKNATEL — TELEFLEX INCORPORATED · Class II
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
- United Medical Industries Co. Ltd
Sources (1)
- FDA UDI ddcac609-f967-454f-a960-9fcc1f3fb124 38 fields · synced May 30, 2026