FDA UDI
In Commercial Distribution
🇺🇸 United States
Switch-It Dual Pro
DI: 00016958060812
·
Model: Dual Pro
·
SUNRISE MEDICAL (US) LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Switch-It Dual Pro
- Primary DI
- 00016958060812
- Version / Model
- Dual Pro
- 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
- 2023-09-14
- Public Version
- 1
- Public Version Date
- 2023-09-22
- Public Version Status
- New
- Public Device Record Key
- 335c0cd4-5049-4707-9a5b-ca1e4211171b
Device Description
The Dual Pro is a truly proportional head array with fine-tuned adjustments and configurability to provide the user an easy-to-learn, precise, and intuitive driving experience.
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 | 00016958060812 | GS1 |