FDA UDI
In Commercial Distribution
🇺🇸 United States
WELLBRACE
DI: 07798128673079
·
Model: 1302-R11 U L
·
PANTYMED S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WELLBRACE
- Primary DI
- 07798128673079
- Version / Model
- 1302-R11 U L
- Company Name
- PANTYMED S.A.
- Labeler DUNS
- 971365986
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-01
- Public Version
- 1
- Public Version Date
- 2024-02-09
- Public Version Status
- New
- Public Device Record Key
- 4aee0344-43d8-4a68-aa80-28401fd065fb
Device Description
OPEN KNEE SUPPORT WITH ARTICULATION SIZE L
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
- 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 |
|---|---|---|---|---|
| ITQ | Joint, Knee, External Brace | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41065 | Knee support orthosis | A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07798128673079 | GS1 |