Esper Bionics

GUDID 04820267110016

ESPER, TOV

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Primary Device ID04820267110016
NIH Device Record Key47b5bb6b-f415-4019-ba28-20083d204227
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsper Bionics
Version Model NumberSize L
Company DUNS538318516
Company NameESPER, TOV
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104820267110016 [Primary]

FDA Product Code

IQZHand, External Limb Component, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-07
Device Publish Date2022-10-28

On-Brand Devices [Esper Bionics]

04820267110023Size S
04820267110016Size L

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