LUKE Arm

GUDID 00859503006107

ARM, SHOULDER, LEFT, W/O BATTERY

MOBIUS BIONICS LLC

Myoelectric hand prosthesis
Primary Device ID00859503006107
NIH Device Record Keyc6c67dcb-0ee3-4060-a283-7300ca925791
Commercial Distribution StatusIn Commercial Distribution
Brand NameLUKE Arm
Version Model NumberLU-10522-XX2
Company DUNS080216821
Company NameMOBIUS BIONICS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859503006107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PAEUpper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-21

On-Brand Devices [LUKE Arm]

00859503006107ARM, SHOULDER, LEFT, W/O BATTERY
00859503006091ARM, SHOULDER, LEFT, W/BATTERY
00859503006084ARM, SHOULDER, RIGHT, W/O BATTERY
00859503006077ARM, SHOULDER, RIGHT, W/BATTERY
00859503006060ARM, HUMERAL, LEFT, W/O BATTERY
00859503006053ARM, HUMERAL, LEFT, W/BATTERY
00859503006046ARM, HUMERAL, RIGHT, W/O BATTERY
00859503006039ARM, HUMERAL, RIGHT, W/BATTERY
00859503006022ARM, RADIAL, LEFT-HANDED
00859503006015ARM, RADIAL, RIGHT-HANDED

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