Identity
- Trade Name
- EndyMed PRO MAX,Mini Shaper MAX Handpiece FDA UDI
- Generic Name
- Multi-modality skin/body contouring system FDA UDI
- Device Name
- The handpiece is used as an accessory to EndyMed PRO MAX system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides. FDA UDI
- Model / Reference
- Mini Shaper MAX Handpiece FDA UDI
- Description
- The handpiece is used as an accessory to EndyMed PRO MAX system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides. FDA UDI
Identifiers
- Catalog Number
- ND_PRD00468-00 FDA UDI
- Primary DI / UDI-DI
- 07290016814460 FDA UDI
- FDA Product Code
- GEI FDA UDIOUH FDA UDI
- GMDN Term
- Multi-modality skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- Not 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
EndyMed PRO MAX, Mini Shaper MAX Handpiece by Endymed Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 f450b9b9-c328-46be-9bb9-6e453aaafeba 36 fields · synced May 30, 2026