Myo Cuff

GUDID 04032767949205

Otto Bock Healthcare Products GmbH

Myoelectric hand prosthesis
Primary Device ID04032767949205
NIH Device Record Key5faa6679-9835-43e8-880a-7a4765afa151
Commercial Distribution Discontinuation2020-03-18
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMyo Cuff
Version Model Number757M20=50-S
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
GS104032767949205 [Primary]

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-20
Device Publish Date2019-09-10

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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