FDA UDI
In Commercial Distribution
🇺🇸 United States
Push braces
DI: 08715669004697
·
Model: 3.10.2.11
·
Nea International B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Push braces
- Primary DI
- 08715669004697
- Version / Model
- 3.10.2.11
- Company Name
- Nea International B.V.
- Labeler DUNS
- 410032197
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-23
- Public Version
- 2
- Public Version Date
- 2023-02-10
- Public Version Status
- Update
- Public Device Record Key
- cfbf759c-176e-4f61-8e42-881e25481341
Device Description
Push ortho Thumb Brace Metagrip L1
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IQI | ORTHOSIS, LIMB BRACE | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41044 | Wrist/hand/finger stable-position orthosis | An externally applied orthopaedic appliance or apparatus designed to maintain both the transverse and longitudinal arches of the hand, and to hold the thumb in a functional position. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08715669004697 | GS1 |
Customer Contacts
- Phone
- +31434079220
- [email protected]