Identity
- Trade Name
- Invisiderm™ Scar Management, Gel Sheet FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- Scar Management, Gel Sheet FDA UDI
- Model / Reference
- Breast Reduction FDA UDI
- Description
- Scar Management, Gel Sheet FDA UDI
Identifiers
- Catalog Number
- IGS-BR FDA UDI
- Primary DI / UDI-DI
- M724IGSBR1 FDA UDI
- 510(k) Number
- K982051 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
No
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
Invisiderm™ Scar Management, Gel Sheet by Implantech Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Scar-management dressing, reusable.
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Cleared under the same submission
K982051 also covers:
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc.
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc.
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc.
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc.
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc.
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc.
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc.
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc.
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc.
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc.
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc.
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Implantech Associates, Inc.
Sources (1)
- FDA UDI a77baad8-19b7-45ef-83a9-a6c96246a214 37 fields · synced Jun 9, 2026