Identity
- Trade Name
- Gazetex® FDA UDI
- Generic Name
- Cotton wool roll FDA UDI
- Device Name
- 4.5 in X 4.1 yards , 6-ply, 12 X 5 mesh gauze bandage roll, crimpled. Sterile. FDA UDI
- Model / Reference
- 9322 FDA UDI
- Description
- 4.5 in X 4.1 yards , 6-ply, 12 X 5 mesh gauze bandage roll, crimpled. Sterile. FDA UDI
Identifiers
- Catalog Number
- DUP9322 FDA UDI
- Primary DI / UDI-DI
- 00809958090220 FDA UDI
- FDA Product Code
- NAB FDA UDI
- GMDN Term
- Cotton wool roll 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
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
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: Cotton wool roll
Gazetex® by Derma Sciences Canada, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- RHINO RESCUE — Wuxi Emsrun Technology Co., Ltd. · Class I
- Safco cotton rolls — Safco Dental Supply · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Derma Sciences Canada, Inc
Sources (1)
- FDA UDI 3799736b-9f6b-4edd-9768-2b13e4d7aa2d 36 fields · synced Jun 6, 2026