FDA UDI
In Commercial Distribution
🇺🇸 United States
DualGrip Digital Grip Dynamometer
DI: 00855170007423
·
Model: 5030DG
·
LAFAYETTE INSTRUMENT COMPANY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DualGrip Digital Grip Dynamometer
- Primary DI
- 00855170007423
- Version / Model
- 5030DG
- Catalog Number
- 5030DG
- Company Name
- LAFAYETTE INSTRUMENT COMPANY, INC.
- Labeler DUNS
- 005080650
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-11
- Public Version
- 1
- Public Version Date
- 2024-09-19
- Public Version Status
- New
- Public Device Record Key
- 62b12924-a219-4f03-954f-220b875803a9
Device Description
The DualGrip Digital Grip Dynamometer is grip strength measuring instrument. It is designed for routine assessment of the grip strength of a patient or can also be used in the evaluation of hand trauma or disease. As the patient grips the device, a load cell measures the applied force. An LCD readout indicates the force in pounds (lbs) or kilogram force (kgf). The grip dynamometer also features an adjustable handle that can accommodate two different grip positions. The DualGrip is designed to be easily held by adults and children with a focus on increased accuracy in the lower range.
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
- Yes
- 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 |
|---|---|---|---|---|
| HRW | Dynamometer, Nonpowered | Orthopedic | 888.1250 | 1 |
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 | 00855170007423 | GS1 |
Customer Contacts
- Phone
- 765-423-1505
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 95 Degrees Fahrenheit