FDA UDI
In Commercial Distribution
🇺🇸 United States
GRIP-X ATHLETIC GRD BLK (10) DURO SPEC A65+ OR -2(63-67)
DI: 00733657221671
·
Model: 5462
·
ALIMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GRIP-X ATHLETIC GRD BLK (10) DURO SPEC A65+ OR -2(63-67)
- Primary DI
- 00733657221671
- Version / Model
- 5462
- Catalog Number
- 2970003477
- Company Name
- ALIMED, INC.
- Labeler DUNS
- 056007248
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-01
- Public Version
- 2
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- 0a28466e-1028-4da6-9a77-60e82ac75bc4
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ION | EXERCISER, NON-MEASURING | Physical Medicine | 890.5370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34200 | Finger/hand exerciser | A non-powered device intended primarily to strengthen the muscles of the fingers and hands through repetitive finger/hand motion against resistance from elasticity, density, magnetism, or other means. It is available in a variety of forms including handgrips (some types with individual buttons to work each finger independently), elastic balls and webs, putty, and hand-held devices with elastic bands. The device may also help improve finger/hand flexibility and coordination, and help improve wrist and forearm strength. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00733657221671 | GS1 |
Customer Contacts
- Phone
- +1(781)329-2900 ext. 0
- [email protected]