Esper Bionics

GUDID 04820267110016

ESPER, TOV

Myoelectric hand prosthesis

• Primary Device ID: 04820267110016
• NIH Device Record Key: 47b5bb6b-f415-4019-ba28-20083d204227
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esper Bionics
• Version Model Number: Size L
• Company DUNS: 538318516
• Company Name: ESPER, TOV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04820267110016 [Primary]

FDA Product Code

• IQZ: Hand, External Limb Component, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-07
• Device Publish Date: 2022-10-28

On-Brand Devices [Esper Bionics]

• 04820267110023: Size S
• 04820267110016: Size L