Identity
- Trade Name
- ProCure FDA UDI
- Generic Name
- Woven gauze roll/sheet FDA UDI
- Device Name
- Kerlix Fluff Bandage Rolls, Woven, 3.4" x 3.1 yards, Non-Sterile 96 ea/cs FDA UDI
- Model / Reference
- PCGF34N FDA UDI
- Description
- Kerlix Fluff Bandage Rolls, Woven, 3.4" x 3.1 yards, Non-Sterile 96 ea/cs FDA UDI
Identifiers
- Catalog Number
- PCGF34N FDA UDI
- Primary DI / UDI-DI
- 10840330702338 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 3.4 Inch FDA UDILength — 3.1 Yard FDA UDI
Category: Woven gauze roll/sheet
ProCure by Twin Med, LLC — 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
- Twin Med, LLC
Sources (1)
- FDA UDI 1a5226ff-037e-48d9-b719-3cff8b4ac60e 36 fields · synced May 30, 2026