Identity
- Trade Name
- Zemits Klein EL FDA UDI
- Generic Name
- Dermabrasion brush, manual FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- 4518 FDA UDI
- Primary DI / UDI-DI
- 00860010841112 FDA UDI
- FDA Product Code
- GFE FDA UDI
- GMDN Term
- Dermabrasion brush, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermabrasion brush, manual
Zemits Klein EL by Advance-Esthetic Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermabrasion brush, manual.
- SaltFacial — Innovative Med, Inc. · Class I
- Dermal Cooling System — R2 Technologies, Inc. · Class I
- Norsen Debrider, Sterile — BELMED, INC. · Class I
- Dermal Cooling System — R2 Technologies, Inc. · Class I
- KMI IMI Group — Innovative Med, Inc. · Class I
- Zemits JoliPeel — ADVANCE-ESTHETIC LLC · Class I
- Zemits DermeLuxx — ADVANCE-ESTHETIC 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advance-Esthetic Llc
Sources (1)
- FDA UDI 5276cdbf-cdac-4928-8b69-a2b5163a219c 34 fields · synced May 30, 2026