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DynaLevin Waterproof Adhesive Bordered Foam Dressing
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- DynaLevin Waterproof Adhesive Bordered Foam Dressing FDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Device Name
- DynaLevin Waterproof Adhesive Bordered Foam Dressing, 4"x4" FDA UDI
- Model / Reference
- 3021 FDA UDI
- Description
- DynaLevin Waterproof Adhesive Bordered Foam Dressing, 4"x4" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784302119 FDA UDI
- FDA Product Code
- NAC FDA UDINAD FDA UDI
- GMDN Term
- Negative-pressure wound therapy system foam dressing, non-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, non-antimicrobial
DynaLevin Waterproof Adhesive Bordered 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, non-antimicrobial.
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- Paraffin gauze dressings — Roosin Medical Co., Ltd. · Class IIa
- Innomed — Zhejiang Longterm Medical Technology Co., Ltd. · Class IIb
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
- Dynarex Corp.
Sources (1)
- FDA UDI b722276a-3893-42e1-8e40-38b9c83f8da6 33 fields · synced May 30, 2026