Identity
- Trade Name
- EndyMed Pure FSR Handpiece FDA UDI
- Generic Name
- Radio-frequency skin surface treatment system applicator FDA UDI
- Device Name
- The handpiece is used as an accessory to EndyMed Pure system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for Dermatological procedures requiring ablation and resurfacing of the skin. FDA UDI
- Model / Reference
- FSR Handpiece FDA UDI
- Description
- The handpiece is used as an accessory to EndyMed Pure system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for Dermatological procedures requiring ablation and resurfacing of the skin. FDA UDI
Identifiers
- Catalog Number
- ND_PRD00141 FDA UDI
- Primary DI / UDI-DI
- 07290016814026 FDA UDI
- FDA Product Code
- OUH FDA UDI
- GMDN Term
- Radio-frequency skin surface treatment system applicator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radio-frequency skin surface treatment system applicator
EndyMed Pure FSR Handpiece by Endymed Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Endymed Medical Ltd
Sources (1)
- FDA UDI dc995c96-d597-4037-b7c9-1ea45d04c38e 35 fields · synced May 30, 2026