Identity
- Trade Name
- Comfortell Composite Dressing (4x4 in FDA UDI
- Generic Name
- Exudate-absorbent dressing, non-gel, non-antimicrobial FDA UDI
- Model / Reference
- GEN-12400 FDA UDI
Identifiers
- Catalog Number
- GEN-12400 FDA UDI
- Primary DI / UDI-DI
- 00361554001999 FDA UDI
- FDA Product Code
- NAC FDA UDI
- GMDN Term
- Exudate-absorbent dressing, non-gel, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Exudate-absorbent dressing, non-gel, non-antimicrobial
Comfortell Composite Dressing (4x4 in by Gentell — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Exudate-absorbent dressing, non-gel, non-antimicrobial.
- ALLEVYN Gentle Border Sacrum Large — Smith & Nephew Medical, Ltd. · Class I
- ULTRA Border — MILLIKEN HEALTHCARE PDTS, LLC · Class I
- NuVeria Labs — REMEDIUM HEALTHCARE PRODUCTS · Class I
- KerraFoam Simple — CRAWFORD HEALTHCARE LIMITED · Class I
- CovaWound™ Foam 5x5 — Covalontechnologies, Inc. · Class I
- Allevyn Life — Smith & Nephew Medical, Ltd. · Class I
- ComfortFoam Border Sacral Healogics by DermaRite — DERMARITE INDUSTRIES LLC · Class I
- 3M™ Tegaderm™ — 3M COMPANY · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gentell
Sources (1)
- FDA UDI 461676fb-66a3-42fa-bc41-a9019c370c12 33 fields · synced May 30, 2026