Identity
- Trade Name
- Simpurity FDA UDI
- Generic Name
- Scar management dressing, single-use, sterile FDA UDI
- Device Name
- Simpurity Silicone Transparent Film Dressing 6" x 6" - Each FDA UDI
- Model / Reference
- SNS57206 FDA UDI
- Description
- Simpurity Silicone Transparent Film Dressing 6" x 6" - Each FDA UDI
Identifiers
- Catalog Number
- SNS57206 FDA UDI
- Primary DI / UDI-DI
- 00810040131653 FDA UDI
- FDA Product Code
- MDA FDA UDI
- GMDN Term
- Scar management dressing, single-use, sterile 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
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
- Width — 6 Inch FDA UDILength — 6 Inch FDA UDI
Category: Scar management dressing, single-use, sterile
Simpurity by Safe N Simple Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scar management dressing, single-use, sterile.
- Mepiform® — Mölnlycke Health Care AB · Class I
- Otological Silicone Strips — Boston Medical Products, Inc. · Class I
- Otological Silicone Strips — Boston Medical Products, Inc. · Class I
- Mepiform® — Mölnlycke Health Care AB · Class I
- ScarMD — AIM MEDICAL INC · Class I
- Mepiform® — Mölnlycke Health Care AB · Class I
- Otological Silicone Strips — Boston Medical Products, Inc. · Class I
- Simpurity — SAFE N SIMPLE LLC · 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
- Safe N Simple Llc
Sources (1)
- FDA UDI d40071fb-7a1a-4644-8c90-8dd0e2d2084d 36 fields · synced May 30, 2026