Identity
- Trade Name
- DuForm® FDA UDI
- Generic Name
- Woven gauze roll/sheet FDA UDI
- Device Name
- 6 in X 145 in relaxed, non-sterile conforming bandage FDA UDI
- Model / Reference
- 75116-5 FDA UDI
- Description
- 6 in X 145 in relaxed, non-sterile conforming bandage FDA UDI
Identifiers
- Catalog Number
- DUP75116-5 FDA UDI
- Primary DI / UDI-DI
- 00809958077115 FDA UDI
- FDA Product Code
- FQM FDA UDI
- GMDN Term
- Woven gauze roll/sheet FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Woven gauze roll/sheet
DuForm is a non-sterile, conforming bandage made from woven gauze roll/sheet, ideal for wound care and dressing retention. It's designed for various applications, such as primary wound dressing, dressing retention, and injury padding and compression.
Similar devices
Also classified as Woven gauze roll/sheet.
- CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class I
- Dukal — Dukal LLC · Class I
- Tronex International, Inc. — TRONEX INTERNATIONAL, INC. · Class I
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- MedSource ABD Pads — MEDSOURCE INTERNATIONAL LLC · Class I
- CONCO CONFORMING 4X4.1 ST 96/CS — HARTMANN USA INC. · Class I
- NPWT Antimicrobial Large Gauze Roll — Smith & Nephew Medical, Ltd. · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Derma Sciences Canada, Inc
Sources (1)
- FDA UDI ee4b2e79-673f-4267-90da-2ce4bd85c1b0 36 fields · synced Jul 20, 2026