My Knee Femoral Cutting Blocks MIS

GUDID 07630030852756

MRI Right Medial #7

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use
Primary Device ID07630030852756
NIH Device Record Key35860b3b-6303-4159-a255-8664d854e033
Commercial Distribution StatusIn Commercial Distribution
Brand NameMy Knee Femoral Cutting Blocks MIS
Version Model Number4.2227
Company DUNS488227125
Company NameMedacta International SA
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
GS107630030852756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630030852756]

Moist Heat or Steam Sterilization


[07630030852756]

Moist Heat or Steam Sterilization


[07630030852756]

Moist Heat or Steam Sterilization


[07630030852756]

Moist Heat or Steam Sterilization


[07630030852756]

Moist Heat or Steam Sterilization


[07630030852756]

Moist Heat or Steam Sterilization


[07630030852756]

Moist Heat or Steam Sterilization


[07630030852756]

Moist Heat or Steam Sterilization


[07630030852756]

Moist Heat or Steam Sterilization


[07630030852756]

Moist Heat or Steam Sterilization


[07630030852756]

Moist Heat or Steam Sterilization


[07630030852756]

Moist Heat or Steam Sterilization


[07630030852756]

Moist Heat or Steam Sterilization


[07630030852756]

Moist Heat or Steam Sterilization


[07630030852756]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2014-11-18

On-Brand Devices [My Knee Femoral Cutting Blocks MIS]

07630030853272MRI Right Lateral #7
07630030853258MRI Right Lateral #6
07630030853234MRI Right Lateral #5
07630030853210MRI Right Lateral #4
07630030853197MRI Right Lateral #3
07630030853173MRI Right Lateral #2
07630030853159MRI Right Lateral #1
07630030853135MRI Left Lateral #7
07630030853111MRI Left Lateral #6
07630030853098MRI Left Lateral #5
07630030853074MRI Left Lateral #4
07630030853050MRI Left Lateral #3
07630030853036MRI Left Lateral #2
07630030853012MRI Left Lateral #1
07630030852763MRI Right Medial #7 Sterile
07630030852756MRI Right Medial #7
07630030852749MRI Right Medial #6 Sterile
07630030852732MRI Right Medial #6
07630030852725MRI Right Medial #5 Sterile
07630030852718MRI Right Medial #5
07630030852701MRI Right Medial #4 Sterile
07630030852695MRI Right Medial #4
07630030852688MRI Right Medial #3 Sterile
07630030852671MRI Right Medial #3
07630030852664MRI Right Medial #2 Sterile
07630030852657MRI Right Medial #2
07630030852640MRI Right Medial #1 Sterile
07630030852633MRI Right Medial #1
07630030852626MRI Left Medial #7 Sterile
07630030852619MRI Left Medial #7
07630030852602MRI Left Medial #6 Sterile
07630030852596MRI Left Medial #6
07630030852589MRI Left Medial #5 Sterile
07630030852572MRI Left Medial #5
07630030852565MRI Left Medial #4 Sterile
07630030852558MRI Left Medial #4
07630030852541MRI Left Medial #3 Sterile
07630030852534MRI Left Medial #3
07630030852527MRI Left Medial #2 Sterile
07630030852510MRI Left Medial #2
07630030852503MRI Left Medial #1 Sterile
07630030852497MRI Left Medial #1
07630030849671CT Right Lateral #7
07630030849657CT Right Lateral #6
07630030849633CT Right Lateral #5
07630030849619CT Right Lateral #4
07630030849596CT Right Lateral #3
07630030849572CT Right Lateral #2
07630030849558CT Right Lateral #1
07630030849534CT Left Lateral #7

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.