Identity
- Trade Name
- POWER DRIVE ART1 FDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Device Name
- MOTOR CONTROL UNIT 2304 for Orthopedics, Spine surgery and Bronchoscopy, for connection of handpieces M4, M5/0, M5/3, S1 and M1, connection for two handpieces and a footswitch, 5.7 inch monochrome Display, compatible with core, U: 120VAC, 50/60Hz, Dim. (wxhxd): 330x155x365mm FDA UDI
- Model / Reference
- 2304007 FDA UDI
- Description
- MOTOR CONTROL UNIT 2304 for Orthopedics, Spine surgery and Bronchoscopy, for connection of handpieces M4, M5/0, M5/3, S1 and M1, connection for two handpieces and a footswitch, 5.7 inch monochrome Display, compatible with core, U: 120VAC, 50/60Hz, Dim. (wxhxd): 330x155x365mm FDA UDI
Identifiers
- Catalog Number
- 2304.007 FDA UDI
- Primary DI / UDI-DI
- 04055207012246 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
- 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
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
Power Drive Art1 by Richard Wolf GmbH — Class I — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Richard Wolf GmbH
Sources (1)
- FDA UDI 0ff2579f-4ab4-4527-a246-7d5222e7caac 36 fields · synced Jun 6, 2026