Identity
- Trade Name
- SCAR AID FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- 4 Pack Silicone Strips, 5.7" x 1.57" (15cm x 4cm) FDA UDI
- Model / Reference
- SCCS-4 FDA UDI
- Description
- 4 Pack Silicone Strips, 5.7" x 1.57" (15cm x 4cm) FDA UDI
Identifiers
- Catalog Number
- SCCS-4 FDA UDI
- Primary DI / UDI-DI
- 00850014883287 FDA UDI
- FDA Product Code
- MDA FDA UDI
- GMDN Term
- Scar-management dressing, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Category: Scar-management dressing, reusable
Scar Aid by Biodermis Llc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Scar-management dressing, reusable.
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- Oleeva Clear 8x12 — BIO MED SCIENCES, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biodermis Llc
Sources (2)
- FDA UDI 1682d52b-aa6f-4612-ae6a-782289e44e2e 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026