Cannulated Femur Nail, Left 12210-380

GUDID 09120047303276

Cannulated Femur Nail, Left, D=10mm, L=380mm

I.T.S. GmbH

Femur intramedullary nail
Primary Device ID09120047303276
NIH Device Record Key0b062e60-e0f1-4220-acf2-a62290e5bcd7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannulated Femur Nail, Left
Version Model Number12210-380
Catalog Number12210-380
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
GS109120047303276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120047303276]

Moist Heat or Steam Sterilization


[09120047303276]

Moist Heat or Steam Sterilization


[09120047303276]

Moist Heat or Steam Sterilization


[09120047303276]

Moist Heat or Steam Sterilization


[09120047303276]

Moist Heat or Steam Sterilization


[09120047303276]

Moist Heat or Steam Sterilization


[09120047303276]

Moist Heat or Steam Sterilization


[09120047303276]

Moist Heat or Steam Sterilization


[09120047303276]

Moist Heat or Steam Sterilization


[09120047303276]

Moist Heat or Steam Sterilization


[09120047303276]

Moist Heat or Steam Sterilization


[09120047303276]

Moist Heat or Steam Sterilization


[09120047303276]

Moist Heat or Steam Sterilization


[09120047303276]

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, Left]

09120047304549Cannulated Femur Nail, Left, D=10mm, L=460mm
09120047304532Cannulated Femur Nail, Left, D=12.0mm, L=400mm
09120047304525Cannulated Femur Nail, Left, D=12.0mm, L=460mm
09120047304440Cannulated Femur Nail, Left, D=10mm, L=420mm
09120047304433Cannulated Femur Nail, Left, D=12.0mm, L=420mm
09120047304426Cannulated Femur Nail, Left, D=12.0mm, L=360mm
09120047303405Cannulated Femur Nail, Left, D=10mm, L=440mm
09120047303382Cannulated Femur Nail, Left, D=10mm, L=400mm
09120047303351Cannulated Femur Nail, Left, D=10mm, L=320mm
09120047303337Cannulated Femur Nail, Left, D=12.0mm, L=380mm
09120047303313Cannulated Femur Nail, Left, D=12.0mm, L=340mm
09120047303306Cannulated Femur Nail, Left, D=12.0mm, L=320mm
09120047303276Cannulated Femur Nail, Left, D=10mm, L=380mm
09120047303269Cannulated Femur Nail, Left, D=10mm, L=360mm
09120047303245Cannulated Femur Nail, Left, D=10mm, L=340mm
09120047303238Cannulated Femur Nail, Left, D=12.0mm, L=440mm
09120047302200Cannulated Femur Nail, Left, D=12.0mm, L=300mm
09120047302163Cannulated Femur Nail, Left, D=10mm, L=300mm

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