FDA UDI
In Commercial Distribution
🇺🇸 United States
Charder
DI: 04719846017030
·
Model: MG4800
·
CHARDER ELECTRONIC CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Charder
- Primary DI
- 04719846017030
- Version / Model
- MG4800
- Company Name
- CHARDER ELECTRONIC CO., LTD.
- Labeler DUNS
- 656102035
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-11
- Public Version
- 1
- Public Version Date
- 2026-02-19
- Public Version Status
- New
- Public Device Record Key
- 8a98ee29-a734-40a7-af8c-17c3bafc0f77
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 |
|---|---|---|---|---|
| 35021 | Hand dynamometer/pinchmeter, mechanical | A non-powered, mechanical 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 and/or pinch strength in clinical or research settings, typically as part of a rehabilitation program for geriatric patients or those who have suffered a stroke. This device is commonly known as a Vigorimeter. It typically consists of various size squeeze bulbs and an analogue manometer to record the exerted effort. The patient will typically be asked to perform the test a few times so that the physician can obtain a mean value. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14719846017037 | GS1 | CTN | 6 | In Commercial Distribution | |
| Primary | 04719846017030 | GS1 |