FDA UDI
In Commercial Distribution
🇺🇸 United States
Wheelchair Break Lever Extension
DI: 00616784027012
·
Model: 10270
·
DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Wheelchair Break Lever Extension
- Primary DI
- 00616784027012
- Version / Model
- 10270
- Company Name
- DYNAREX CORPORATION
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-22
- Public Version
- 1
- Public Version Date
- 2021-04-30
- Public Version Status
- New
- Public Device Record Key
- 5cd74480-714e-40df-9447-aad5129e4928
Device Description
Wheelchair Break Lever Extension 11 inch; pair
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
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 32989 | Wheelchair brake extension | A metal lever with handle designed to be attached to an existing wheelchair brake lever, to improve handling/leverage for a wheelchair occupant who has difficulty operating the standard brake lever. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784027043 | GS1 | Shipper | 25 | In Commercial Distribution | |
| Primary | 00616784027012 | GS1 |