Identity
- Trade Name
- Simpurity FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- Simpurity Hydrogel Wound Filler in a 25g Tube FDA UDI
- Model / Reference
- SNS58825 FDA UDI
- Description
- Simpurity Hydrogel Wound Filler in a 25g Tube FDA UDI
Identifiers
- Catalog Number
- SNS58825 FDA UDI
- Primary DI / UDI-DI
- 00810040134401 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- Wound hydrogel dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4022 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
Category: Wound hydrogel dressing, non-antimicrobial
Simpurity by Safe N Simple Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound hydrogel dressing, non-antimicrobial.
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- CareOne — Ahold U.S.A., Inc. · Class I
- NAR — NORTH AMERICAN RESCUE, LLC. · Class I
- Halo — Medical Devices Inc. · 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 da6c4590-ee5f-4466-9feb-a06639fc22ff 34 fields · synced May 30, 2026