Myo Cuff

GUDID 04064411256032

Otto Bock Healthcare Products GmbH

Myoelectric hand prosthesis
Primary Device ID04064411256032
NIH Device Record Key9b9053fc-e991-4b0d-bcd1-c5944affe049
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyo Cuff
Version Model Number757M20=50-OB
Company DUNS300802068
Company NameOtto Bock Healthcare Products GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS104064411256032 [Primary]

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-27
Device Publish Date2020-03-19

On-Brand Devices [Myo Cuff]

04032767949205757M20=50-S
04032767946808757M20=60-OB
04032767946792757M20=60
04032767946785757M20=50-OB
04032767946778757M20=50
04064411256063757M20=60-OB
04064411256056757M20=60
04064411256049757M20=50-S
04064411256032757M20=50-OB
04064411256025757M20=50

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