Identity
- Trade Name
- POWER STICK M5/3 FDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Device Name
- MOTOR HANDPIECE MAX. 16000RPM with fixed connection cable, for use with rotation tools, with three function buttons, control optional by footswitch, reusable FDA UDI
- Model / Reference
- 8995500031 FDA UDI
- Description
- MOTOR HANDPIECE MAX. 16000RPM with fixed connection cable, for use with rotation tools, with three function buttons, control optional by footswitch, reusable FDA UDI
Identifiers
- Catalog Number
- 8995500031 FDA UDI
- Primary DI / UDI-DI
- 04055207036709 FDA UDI
- FDA Product Code
- GEY FDA UDI
- GMDN Term
- Surgical power tool system control unit, line-powered 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical power tool system control unit, line-powered
Power Stick M5/3 by Richard Wolf GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical power tool system control unit, line-powered.
- Set iOptima int-2xMX2-Light — Bien-Air Dental SA · Class I
- Console Optima MX2 INT — Bien-Air Dental SA · Class I
- Console iOptima — Bien-Air Dental SA · Class I
- AMADEO M-UK1023 — W & H Dentalwerk Bürmoos GmbH · Class II
- SET STUDENTS BAUSA 13 — Bien-Air Dental SA · Class I
- OSADA PEDO-30W — OSADA ELECTRIC CO., LTD. · Class I
- Set Optima INT MCX + B24-32V — Bien-Air Dental SA · Class I
- Set OSSEODUO + S120 — Bien-Air Surgery SA · Class II
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
- Richard Wolf GmbH
Sources (1)
- FDA UDI 47db4cdb-b959-4f86-98bd-a383b51d36a9 36 fields · synced Jun 8, 2026