Model: 757M20-2=60
DI: 04064411008129
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8f18b5d4-be1c-4581-880b-a16007b3cfd3
Distribution Status:
In Commercial Distribution
DUNS Number:
300802068
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04064411008129
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 41497
Name: Myoelectric hand prosthesis
Definition:
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.
FDA Product Codes
GXY
Electrode, Cutaneous
IQZ
Hand, External Limb Component, Powered