FDA UDI
In Commercial Distribution
🇺🇸 United States
TASKA HandGen2 Myoelectric Hand - 8 1/4 LH LP Sand
DI: 09421906785081
·
Model: TASKA-B2CC21-U1
·
TASKA PROSTHETICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TASKA HandGen2 Myoelectric Hand - 8 1/4 LH LP Sand
- Primary DI
- 09421906785081
- Version / Model
- TASKA-B2CC21-U1
- Company Name
- TASKA PROSTHETICS LIMITED
- Labeler DUNS
- 594832527
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-07
- Public Version
- 1
- Public Version Date
- 2026-01-15
- Public Version Status
- New
- Public Device Record Key
- 374d06da-2eb6-4a77-9e82-34374c0eed8e
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 |
|---|---|---|---|---|
| IQZ | Hand, External Limb Component, Powered | Physical Medicine | 890.3420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41497 | Myoelectric hand prosthesis | A powered artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to replace the appearance and some of the function of the hand. The device features an integral or proximally mounted motor (e.g., electric, hydraulic) which actuates hand/finger movements (e.g., gripping, pinching, pointing). The control of movement is achieved through amplified muscle action potentials from voluntary contracting muscle in the residual limb/trunk, transmitted via surface electrodes in the device that make contact with the skin, which turn on the motor to provide a function. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09421906785081 | GS1 |