Identity
- Trade Name
- Dutex® FDA UDI
- Generic Name
- Woven gauze roll/sheet FDA UDI
- Device Name
- 3 in X 4.5 yards, 2 ply, 20X12 mesh gauze 100% cotton non-sterilized bandage roll. FDA UDI
- Model / Reference
- 76782 FDA UDI
- Description
- 3 in X 4.5 yards, 2 ply, 20X12 mesh gauze 100% cotton non-sterilized bandage roll. FDA UDI
Identifiers
- Catalog Number
- DUP76782 FDA UDI
- Primary DI / UDI-DI
- 00809958070918 FDA UDI
- FDA Product Code
- NAB FDA UDI
- GMDN Term
- Woven gauze roll/sheet FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4014 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
Dutex® by Derma Sciences Canada, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Derma Sciences Canada, Inc
Sources (1)
- FDA UDI 1c083b7e-86b1-4948-a899-bc663c12ef13 36 fields · synced Jun 6, 2026