Identity
- Trade Name
- CovaWound™ Silicone 10x10 FDA UDI
- Generic Name
- Exudate-absorbent dressing, non-gel, non-antimicrobial FDA UDI
- Device Name
- Self-Adherent Soft Silicone Foam Dressing with Border (Lite) FDA UDI
- Model / Reference
- 1031010 FDA UDI
- Description
- Self-Adherent Soft Silicone Foam Dressing with Border (Lite) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00825439014363 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Exudate-absorbent dressing, non-gel, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Centimeter FDA UDIWidth — 10 Centimeter FDA UDI
Category: Exudate-absorbent dressing, non-gel, non-antimicrobial
CovaWound™ Silicone 10x10 by Covalontechnologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Exudate-absorbent dressing, non-gel, non-antimicrobial.
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- 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
- 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 |
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Manufacturer
- Manufacturer
- Covalontechnologies, Inc.
Sources (1)
- FDA UDI e11bb514-ce8d-46b9-a5a7-5fcaf79f60d1 35 fields · synced Jun 6, 2026