FDA UDI
In Commercial Distribution
🇺🇸 United States
Heavy Duty Clamp complete, Black
DI: 04032767358595
·
Model: 477L52=SK055
·
Otto Bock Mobility Solutions GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Heavy Duty Clamp complete, Black
- Primary DI
- 04032767358595
- Version / Model
- 477L52=SK055
- Company Name
- Otto Bock Mobility Solutions GmbH
- Labeler DUNS
- 341148586
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-09
- Public Version
- 1
- Public Version Date
- 2024-04-17
- Public Version Status
- New
- Public Device Record Key
- e984a464-fbc9-4fce-9d9b-6318a5703a75
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
- Yes
- 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 |
|---|---|---|---|---|
| KNN | Components, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45887 | Wheelchair head/trunk support, prefabricated | A prefabricated (non-customized) padded and contoured device designed to attach to the back/seat of a wheelchair to provide the wheelchair occupant with head and trunk postural support and comfort. It may include armrests, a cushioned seat, a belt/harness, thigh support, and/or a tray table. It might additionally be designed for use as a car seat to provide support in vehicles during transportation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04032767358595 | GS1 |