FDA UDI
In Commercial Distribution
🇺🇸 United States
X1
DI: 04055207063811
·
Model: 809510005
·
Richard Wolf GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- X1
- Primary DI
- 04055207063811
- Version / Model
- 809510005
- Catalog Number
- 809510005
- 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
- 2
- Public Version Date
- 2025-12-12
- Public Version Status
- Update
- Public Device Record Key
- 45c18553-95fc-471d-b489-ee9f8e9b0230
Device Description
HIGH-SPEED-MOTOR MAX. 50000RPM for use with High-Speed-attachments, control by footswitch, reusable
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 | 04055207063811 | GS1 |
Customer Contacts
- Phone
- +497043350
- [email protected]