Distal Femur Plate 21302-13

GUDID 09120034307089

Distal Femur Plate, 13-Hole, Left

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID09120034307089
NIH Device Record Key14efe814-fbf9-4cf7-b0ce-d6b1e002769b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDistal Femur Plate
Version Model Number21302-13
Catalog Number21302-13
Company DUNS303456917
Company NameI.T.S. GmbH
Device Count1
DM Exempttrue
Pre-market Exempttrue
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 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
GS109120034307089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


[09120034307089]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-07
Device Publish Date2016-09-08

On-Brand Devices [Distal Femur Plate]

09120047299838Distal Femur Plate, 11-Hole, Left
09120034307089Distal Femur Plate, 13-Hole, Left

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