FDA UDI
In Commercial Distribution
🇺🇸 United States
POWERSPEED AS1
DI: 04055207056660
·
Model: 2305001
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- POWERSPEED AS1
- Primary DI
- 04055207056660
- Version / Model
- 2305001
- Catalog Number
- 2305001
- Company Name
- Richard Wolf GmbH
- Labeler DUNS
- 315304071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-08
- Public Version
- 5
- Public Version Date
- 2025-12-12
- Public Version Status
- Update
- Public Device Record Key
- ff3b224c-4536-47d4-bb63-ea6685387c3c
Device 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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEY | MOTOR, SURGICAL INSTRUMENT, AC-POWERED | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41264 | Surgical power tool system control unit, line-powered | A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04055207056660 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity