MISHA(TM) Torque Limiting Driver 1-4039

GUDID 00856047005917

Moximed, Inc.

Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID00856047005917
NIH Device Record Key256f6087-2bf2-47f7-aa84-5b21bda6529e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMISHA(TM) Torque Limiting Driver
Version Model Number102889
Catalog Number1-4039
Company DUNS808178383
Company NameMoximed, Inc.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100856047005917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QVVMedial Knee Implanted Shock Absorber

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-15
Device Publish Date2023-05-05

Devices Manufactured by Moximed, Inc.

00856047005795 - MISHA(TM) Knee System, Small, Left2023-05-15
00856047005801 - MISHA(TM) Knee System, Small, Right2023-05-15
00856047005818 - MISHA(TM) Knee System, Large, Left2023-05-15
00856047005825 - MISHA(TM) Knee System, Large, Right2023-05-15
00856047005832 - MISHA(TM) Locking Screw, 5.0 x 46 mm, 6-Pack2023-05-15
00856047005849 - MISHA(TM) Locking Screw, 5.0 x 46 mm, 1-Pack2023-05-15
00856047005856 - MISHA(TM) Trial, Small, Left2023-05-15
00856047005863 - MISHA(TM) Trial, Small, Right2023-05-15

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