FDA UDI
In Commercial Distribution
🇺🇸 United States
Stander Outback Drop Cantilever Armrests (Set)
DI: 07540147002565
·
Model: D-0214-OSCCA
·
Motion Concepts Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Stander Outback Drop Cantilever Armrests (Set)
- Primary DI
- 07540147002565
- Version / Model
- D-0214-OSCCA
- Catalog Number
- OSCCA
- Company Name
- Motion Concepts Inc
- Labeler DUNS
- 259777209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- ee866562-ad8d-4839-8b90-7454fcec73b6
Device Description
Stander Outback Drop Cantilever Armrests (set) are attached to the recline back canes on the Motion Concepts Modular Power Standing Systems (MPSS). The outback design allows armrest to flip outward and backwards to provide maximum clearance for side transfers. Armrest is height and angle adjustable. Drop armrest is designed with a 4" downward offset in the armrest tube.
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
- No
- 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 |
|---|---|---|---|---|
| IML | Armrest, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32981 | Wheelchair armrest | A small platform, typically cushioned, mounted on the lateral ends of a wheelchair to provide the user with a support on which to place the arms. The position of the platform (e.g., height) may be adjustable to suit the comfort and utility of the user. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540147002565 | GS1 |
Customer Contacts
- Phone
- 1-888-433-6818
- [email protected]