Proximal Lateral Tibia Plate 21321-17

GUDID 09120034307119

Proximal Lateral Tibia Plate, 17-Hole, Right

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID09120034307119
NIH Device Record Key1b2f08d0-0aef-4173-8f41-df7743817e1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameProximal Lateral Tibia Plate
Version Model Number21321-17
Catalog Number21321-17
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
GS109120034307119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

Moist Heat or Steam Sterilization


[09120034307119]

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 [Proximal Lateral Tibia Plate]

09120034309311Proximal Lateral Tibia Plate, 4-Hole, Left
09120034309304Proximal Lateral Tibia Plate, 4-Hole, Right
09120034307140Proximal Lateral Tibia Plate, 17-Hole, Left
09120034307133Proximal Lateral Tibia Plate, 12-Hole, Left
09120034307126Proximal Lateral Tibia Plate, 7-Hole, Left
09120034307119Proximal Lateral Tibia Plate, 17-Hole, Right
09120034307102Proximal Lateral Tibia Plate, 12-Hole, Right
09120034307096Proximal Lateral Tibia Plate, 7-Hole, Right

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