Esper Bionics

Basic Information

• Brand Name: Esper Bionics
• Primary DI: 04820267110016
• Version / Model: Size L
• Company Name: ESPER, TOV
• Labeler DUNS: 538318516
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-28
• Public Version: 1
• Public Version Date: 2022-11-07
• Public Version Status: New
• Public Device Record Key: 47b5bb6b-f415-4019-ba28-20083d204227

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 moves as the result of a motor(s) that may be integral or proximally mounted with a mechanical link. 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	04820267110016	GS1