← Back to catalogue
Circular Split Drain Foam Dressing (4 in) Diameter
FDA UDIClass I (US FDA UDI)
by Gentell
Identity
- Trade Name
- Circular Split Drain Foam Dressing (4 in) Diameter FDA UDI
- Generic Name
- Non-woven gauze pad FDA UDI
- Model / Reference
- GEN-14410 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00361554001609 FDA UDI
- FDA Product Code
- NAC FDA UDI
- GMDN Term
- Non-woven gauze pad 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: Non-woven gauze pad
Circular Split Drain Foam Dressing (4 in) Diameter by Gentell — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-woven gauze pad.
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
- Top Quality Manufacturing — TOP QUALITY MANUFACTURING, INC. · Class I
- MedSource Gauze — MEDSOURCE INTERNATIONAL LLC · Class I
- AMD-Ritmed — AMD Medicom Inc · Class I
- H-E-B — H. E. BUTT GROCERY COMPANY · Class I
- 16PW - Class A Burn Relief — Certified Safety Manufacturing, Inc. · Class I
- 16PW - Class A Blue Metal Detectable - Poly White — Certified Safety Manufacturing, Inc. · U
- EMT - Class B Trauma - Bag — Certified Safety Manufacturing, Inc. · 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 5fd514cd-86b5-4056-b39d-54380ff151bf 32 fields · synced May 30, 2026