MISHA(TM) Fixation Kit 2-3001

GUDID 00856047005894

Moximed, Inc.

Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID00856047005894
NIH Device Record Key3d0386cd-91d5-4be5-aa59-1219b5069ac2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMISHA(TM) Fixation Kit
Version Model Number102809
Catalog Number2-3001
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
GS100856047005894 [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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