Identity
- Trade Name
- CuraFoam Foam Dressing FDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, antimicrobial FDA UDI
- Device Name
- CuraFoam Foam Dressing 2"x2" FDA UDI
- Model / Reference
- 3011 FDA UDI
- Description
- CuraFoam Foam Dressing 2"x2" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784301112 FDA UDI
- FDA Product Code
- NAC FDA UDINAD FDA UDI
- GMDN Term
- Negative-pressure wound therapy system foam dressing, antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 FDA UDI878.4020 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Negative-pressure wound therapy system foam dressing, antimicrobial
CuraFoam Foam Dressing by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy system foam dressing, antimicrobial.
- AG Foam Kit Medium — GENADYNE BIOTECHNOLOGIES INC. · Class II
- V.A.C.® GRANUFOAM™ Silver™ — KCI USA, INC. · Class II
- AG Foam Kit Small — GENADYNE BIOTECHNOLOGIES, INC. · Class II
- V.A.C.® GRANUFOAM™ Silver™ — KCI USA, INC. · Class II
- AG Foam Kit Large — GENADYNE BIOTECHNOLOGIES INC. · Class II
- Silver ProFoam Hydrophobic Dressing, Medium — Pensar Medical, LLC · Class II
- V.A.C.® GRANUFOAM™ Silver™ — KCI USA, INC. · Class II
- Silver ProFoam Hydrophobic Dressing, Large — Pensar Medical, LLC · Class II
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
- Dynarex Corp.
Sources (1)
- FDA UDI a8c9b13a-d78a-44fd-9f58-3e26795f5b8a 33 fields · synced May 30, 2026