FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AcroGrip™ Device
DI: 10850828007012
·
Model: EN-247
·
AXOGEN CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AcroGrip™ Device
- Primary DI
- 10850828007012
- Version / Model
- EN-247
- Company Name
- AXOGEN CORPORATION
- Labeler DUNS
- 113424464
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-15
- Public Version
- 5
- Public Version Date
- 2025-11-25
- Public Version Status
- Update
- Public Device Record Key
- b74eaf51-e11e-45c2-a85d-c63d0060678e
- Distribution End Date
- 2019-11-30
Device Description
Hand dynamometer intended for use with the AcroVal™ Neurosensory & Motor Testing System (NSMTS) to measure grasp strength.
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| LBB | Dynamometer, Ac-Powered | Orthopedic | 888.1240 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33785 | Hand dynamometer/pinchmeter, electronic | An electrically-powered instrument designed to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. It is used to assess a patient's grip strength in clinical or research settings, typically as part of a rehabilitation program for geriatric patients or those who have suffered a stroke; it may in addition be designed to be used as part of an interactive rehabilitation system whereby forces applied by the patient translate to movements in a video-game. It includes a force transducer to translate force into electrical impulses for measurement. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850828007012 | GS1 |
Customer Contacts
- Phone
- 888.296.4361
- [email protected]