Identity
- Trade Name
- POWERSPEED AS1 FDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Device Name
- MOTOR CONTROL UNIT 2305 for Orthopedics, Spine surgery and Bronchoscopy, for connection of motor handle M4. M5/0. M5/3. S1. M1 and High-Speed Motor X1, connection for two handpieces and a footswitch, 6.5" Touch Screen color display, compatible with core nova, U: 100-240VAC, 50/60Hz, Dim. (wxhxd): 300x159.5x404mm FDA UDI
- Model / Reference
- 2305001 FDA UDI
- Description
- MOTOR CONTROL UNIT 2305 for Orthopedics, Spine surgery and Bronchoscopy, for connection of motor handle M4. M5/0. M5/3. S1. M1 and High-Speed Motor X1, connection for two handpieces and a footswitch, 6.5" Touch Screen color display, compatible with core nova, U: 100-240VAC, 50/60Hz, Dim. (wxhxd): 300x159.5x404mm FDA UDI
Identifiers
- Catalog Number
- 2305001 FDA UDI
- Primary DI / UDI-DI
- 04055207056660 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
Yes
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
Category: Surgical power tool system control unit, line-powered
Powerspeed As1 by Richard Wolf GmbH — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
Sources (1)
- FDA UDI ff3b224c-4536-47d4-bb63-ea6685387c3c 36 fields · synced May 30, 2026