FDA UDI
In Commercial Distribution
🇺🇸 United States
Elbow support
DI: 07350111831530
·
Model: 10-366-US
·
Reison Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Elbow support
- Primary DI
- 07350111831530
- Version / Model
- 10-366-US
- Company Name
- Reison Medical AB
- Labeler DUNS
- 356766220
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-30
- Public Version
- 1
- Public Version Date
- 2022-05-09
- Public Version Status
- New
- Public Device Record Key
- ef456246-aacb-4411-a414-77789132d2ca
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 |
|---|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41455 | Shoulder/elbow/wrist/hand orthosis | An externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the shoulder, elbow, wrist, and hand. The device may be an articulated single item or a collection of compatible units specific for various parts of the arm; it may be powered by the body or electrically. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350111831530 | GS1 |