Identity
- Trade Name
- ComfortFoam/Ag FDA UDI
- Generic Name
- Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
- Model / Reference
- 49660 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00714196391063 FDA UDI
- 510(k) Number
- K160022 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Exudate-absorbent dressing, non-gel, antimicrobial
ComfortFoam/Ag by Dermarite Industries Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Exudate-absorbent dressing, non-gel, antimicrobial.
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Cleared under the same submission
K160022 also covers:
- ComfortFoam/Ag — DERMARITE INDUSTRIES LLC
- ComfortFoam/Ag — DERMARITE INDUSTRIES LLC
- ComfortFoam/Ag — DERMARITE INDUSTRIES LLC
- ComfortFoam/Ag — DERMARITE INDUSTRIES LLC
- ComfortFoam/Ag — DERMARITE INDUSTRIES LLC
- ComfortFoam/Ag Healogics by DermaRite — DERMARITE INDUSTRIES LLC
- ComfortFoam/Ag Healogics by DermaRite — DERMARITE INDUSTRIES LLC
- Zeni Medical — FOCUS HEALTH GROUP
- Suprasorb P Sensitive Ag — L&R USA INC.
- Suprasorb P Sensitive Ag — L&R USA INC.
- Suprasorb P Sensitive Ag — L&R USA INC.
- Suprasorb P Sensitive Ag — L&R USA INC.
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 U | Pending data |
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Manufacturer
- Manufacturer
- Dermarite Industries Llc
Sources (1)
- FDA UDI 2dc5f53e-8047-42af-9b62-c3cd57a4d362 33 fields · synced May 30, 2026