My Knee Femoral Cutting Blocks

GUDID 07630030851971

MRI Left Lateral #1

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use
Primary Device ID07630030851971
NIH Device Record Keyf38e5931-12e7-49dc-8eda-cc358e61cf8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMy Knee Femoral Cutting Blocks
Version Model Number4.2061
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
GS107630030851971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOGKnee Arthroplasty Implantation System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630030851971]

Moist Heat or Steam Sterilization


[07630030851971]

Moist Heat or Steam Sterilization


[07630030851971]

Moist Heat or Steam Sterilization


[07630030851971]

Moist Heat or Steam Sterilization


[07630030851971]

Moist Heat or Steam Sterilization


[07630030851971]

Moist Heat or Steam Sterilization


[07630030851971]

Moist Heat or Steam Sterilization


[07630030851971]

Moist Heat or Steam Sterilization


[07630030851971]

Moist Heat or Steam Sterilization


[07630030851971]

Moist Heat or Steam Sterilization


[07630030851971]

Moist Heat or Steam Sterilization


[07630030851971]

Moist Heat or Steam Sterilization


[07630030851971]

Moist Heat or Steam Sterilization


[07630030851971]

Moist Heat or Steam Sterilization


[07630030851971]

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]

07630030852244MRI Right Lateral #7 Sterile
07630030852237MRI Right Lateral #7
07630030852220MRI Right Lateral #6 Sterile
07630030852213MRI Right Lateral #6
07630030852206MRI Right Lateral #5 Sterile
07630030852190MRI Right Lateral #5
07630030852183MRI Right Lateral #4 Sterile
07630030852176MRI Right Lateral #4
07630030852169MRI Right Lateral #3 Sterile
07630030852152MRI Right Lateral #3
07630030852145MRI Right Lateral #2 Sterile
07630030852138MRI Right Lateral #2
07630030852121MRI Right Lateral #1 Sterile
07630030852114MRI Right Lateral #1
07630030852107MRI Left Lateral #7 Sterile
07630030852091MRI Left Lateral #7
07630030852084MRI Left Lateral #6 Sterile
07630030852077MRI Left Lateral #6
07630030852060MRI Left Lateral #5 Sterile
07630030852053MRI Left Lateral #5
07630030852046MRI Left Lateral #4 Sterile
07630030852039MRI Left Lateral #4
07630030852022MRI Left Lateral #3 Sterile
07630030852015MRI Left Lateral #3
07630030852008MRI Left Lateral #2 Sterile
07630030851995MRI Left Lateral #2
07630030851988MRI Left Lateral #1 Sterile
07630030851971MRI Left Lateral #1
07630030851728MRI Right Medial #7 Sterile
07630030851711MRI Right Medial #7
07630030851704MRI Right Medial #6 Sterile
07630030851698MRI Right Medial #6
07630030851681MRI Right Medial #5 Sterile
07630030851674MRI Right Medial #5
07630030851667MRI Right Medial #4 Sterile
07630030851650MRI Right Medial #4
07630030851643MRI Right Medial #3 Sterile
07630030851636MRI Right Medial #3
07630030851629MRI Right Medial #2 Sterile
07630030851612MRI Right Medial #2
07630030851605MRI Right Medial #1 Sterile
07630030851599MRI Right Medial #1
07630030851582MRI Left Medial #7 Sterile
07630030851575MRI Left Medial #7
07630030851568MRI Left Medial #6 Sterile
07630030851551MRI Left Medial #6
07630030851544MRI Left Medial #5 Sterile
07630030851537MRI Left Medial #5
07630030851520MRI Left Medial #4 Sterile
07630030851513MRI Left Medial #4

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