Identity
- Trade Name
- PRO-SIL FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- PRO-SIL 4.25g Tube FDA UDI
- Model / Reference
- PRO-DL-111 FDA UDI
- Description
- PRO-SIL 4.25g Tube FDA UDI
Identifiers
- Catalog Number
- PRO-DL-111 FDA UDI
- Primary DI / UDI-DI
- 00852260000999 FDA UDI
- 510(k) Number
- K003948 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
No
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
Pro-Sil by Biodermis Llc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Scar-management dressing, reusable.
- MEDLOT — Henan Maidingkang Medical Technology Co., Ltd. · Class I
- Blister plaster — Shenzhen Huashengyuan Technology Co., Ltd · Class I
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- Wound Plaster — Jinhua Jingdi Medical Supplies Co.,Ltd. · Class I
- Oleeva Fabric 2x8 — BIO MED SCIENCES, INC. · Class I
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc. · Class I
- Oleeva Clear 8x12 — BIO MED SCIENCES, INC. · Class I
Cleared under the same submission
K003948 also covers:
- DERMASOF — BIODERMIS LLC
- Vivera Pharmaceuticals — VIVERA PHARMACEUTICALS, INC.
- szosil medical grade silicone gel sheeting for scar — VIVERA PHARMACEUTICALS, INC.
- szosil medical grade silicone sheeting gel for scars — VIVERA PHARMACEUTICALS, INC.
- szosil silicone stick — VIVERA PHARMACEUTICALS, INC.
- szosil skin repair serum — VIVERA PHARMACEUTICALS, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biodermis Llc
Sources (2)
- FDA UDI 771620cf-3218-44a5-be88-58c87e5639d0 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026