Identity
- Trade Name
- Silagen 100% Pure Silicone Gel FDA UDI
- Generic Name
- Scar-management dressing, single-use FDA UDI
- Device Name
- 6115 Silagen Pure Silicone Gel, 0.5oz. (15 gram), 1 bottle/package FDA UDI
- Model / Reference
- 6115 FDA UDI
- Description
- 6115 Silagen Pure Silicone Gel, 0.5oz. (15 gram), 1 bottle/package FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816465020213 FDA UDI
- FDA Product Code
- MDA FDA UDI
- GMDN Term
- Scar-management dressing, single-use 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
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Scar-management dressing, single-use
Silagen 100% Pure Silicone Gel by Newmedical Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scar-management dressing, single-use.
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- ScarMD — AIM MEDICAL INC · Class I
- ScarAway Silicone Scar Gel — ALLIANCE PHARMA INC. · Class I
- Lorski — Shandong Zhushi Pharmaceutical Group Co., Ltd. First Office · Class I
- NEW BEGINNINGS® GELSHAPES® — Pmt Corp. · 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
- Newmedical Technology, Inc.
Sources (1)
- FDA UDI 13142e7e-c21a-4c9e-b996-09252ce1b6e7 35 fields · synced Jun 9, 2026