Cannulated Femur Nail, Right 12112-320

GUDID 09120047303290

Cannulated Femur Nail, Right, D=12.0mm, L=320mm

I.T.S. GmbH

Femur intramedullary nail
Primary Device ID09120047303290
NIH Device Record Key2732db2e-00fb-4e8f-8a89-182346f2e617
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannulated Femur Nail, Right
Version Model Number12112-320
Catalog Number12112-320
Company DUNS303456917
Company NameI.T.S. GmbH
Device Count1
DM Exempttrue
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 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
GS109120047303290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120047303290]

Moist Heat or Steam Sterilization


[09120047303290]

Moist Heat or Steam Sterilization


[09120047303290]

Moist Heat or Steam Sterilization


[09120047303290]

Moist Heat or Steam Sterilization


[09120047303290]

Moist Heat or Steam Sterilization


[09120047303290]

Moist Heat or Steam Sterilization


[09120047303290]

Moist Heat or Steam Sterilization


[09120047303290]

Moist Heat or Steam Sterilization


[09120047303290]

Moist Heat or Steam Sterilization


[09120047303290]

Moist Heat or Steam Sterilization


[09120047303290]

Moist Heat or Steam Sterilization


[09120047303290]

Moist Heat or Steam Sterilization


[09120047303290]

Moist Heat or Steam Sterilization


[09120047303290]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-09-04
Device Publish Date2016-09-14

On-Brand Devices [Cannulated Femur Nail, Right]

09120047304501Cannulated Femur Nail, Right, D=12.0mm, L=460mm
09120047304495Cannulated Femur Nail, Right, D=12.0mm, L=340mm
09120047304488Cannulated Femur Nail, Right, D=10mm, L=340mm
09120047304419Cannulated Femur Nail, Right, D=12.0mm, L=360mm
09120047303429Cannulated Femur Nail, Right, D=12.0mm, L=400mm
09120047303412Cannulated Femur Nail, Right, D=10mm, L=460mm
09120047303399Cannulated Femur Nail, Right, D=10mm, L=440mm
09120047303375Cannulated Femur Nail, Right, D=10mm, L=400mm
09120047303368Cannulated Femur Nail, Right, D=10mm, L=380mm
09120047303344Cannulated Femur Nail, Right, D=10mm, L=320mm
09120047303320Cannulated Femur Nail, Right, D=12.0mm, L=380mm
09120047303290Cannulated Femur Nail, Right, D=12.0mm, L=320mm
09120047303283Cannulated Femur Nail, Right, D=10mm, L=420mm
09120047303252Cannulated Femur Nail, Right, D=10mm, L=360mm
09120047303221Cannulated Femur Nail, Right, D=12.0mm, L=440mm
09120047303214Cannulated Femur Nail, Right, D=12.0mm, L=420mm
09120047302194Cannulated Femur Nail, Right, D=12.0mm, L=300mm
09120047302156Cannulated Femur Nail, Right, D=10mm, L=300mm

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