FDA UDI
In Commercial Distribution
🇺🇸 United States
Switch-It VersaGuide
DI: 00016958060843
·
Model: VersaGuide, Versaguide EZ
·
SUNRISE MEDICAL (US) LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Switch-It VersaGuide
- Primary DI
- 00016958060843
- Version / Model
- VersaGuide, Versaguide EZ
- Catalog Number
- SWI
- Company Name
- SUNRISE MEDICAL (US) LLC
- Labeler DUNS
- 962525056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-06
- Public Version
- 1
- Public Version Date
- 2023-10-16
- Public Version Status
- New
- Public Device Record Key
- b3f0472a-89ce-4bd8-a05e-5eea6e2f6ded
Device Description
The VersaGuide is a fully proportional and durable compact joystick that can be mounted virtually anywhere. Its unlimited mounting options are what give the versatile VersaGuide its name. The VersaGuide provides for proportional control (forward, reverse, left, and right). The VersaGuide EZ provides two built-in connections for mode and on/off on the underside of the joystick. Unique to the VersaGuide EZ is the SmartJack sensor input which will automatically adapt to both proximity and mechanical switches.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| KNO | Accessories, Wheelchair | Physical Medicine | 890.3910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30018 | Wheelchair steering/control unit | An electronic device used by a wheelchair occupant or attendant to guide the wheelchair's movements and direction of travel. This device may be operated by the occupant's hand, mouth, or signals provided by other means, or by the attendant as required. This device will include the installation package. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00016958060843 | GS1 |