Cannulated Tibia Nail 11209-285

GUDID 09120047301364

Cannulated Tibia Nail, D=9.0mm, L=285mm

I.T.S. GmbH

Tibia intramedullary nail
Primary Device ID09120047301364
NIH Device Record Key4f67d1c7-aeb0-4204-b750-af78d729b915
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannulated Tibia Nail
Version Model Number11209-285
Catalog Number11209-285
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
GS109120047301364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120047301364]

Moist Heat or Steam Sterilization


[09120047301364]

Moist Heat or Steam Sterilization


[09120047301364]

Moist Heat or Steam Sterilization


[09120047301364]

Moist Heat or Steam Sterilization


[09120047301364]

Moist Heat or Steam Sterilization


[09120047301364]

Moist Heat or Steam Sterilization


[09120047301364]

Moist Heat or Steam Sterilization


[09120047301364]

Moist Heat or Steam Sterilization


[09120047301364]

Moist Heat or Steam Sterilization


[09120047301364]

Moist Heat or Steam Sterilization


[09120047301364]

Moist Heat or Steam Sterilization


[09120047301364]

Moist Heat or Steam Sterilization


[09120047301364]

Moist Heat or Steam Sterilization


[09120047301364]

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 Tibia Nail]

09120047304471Cannulated Tibia Nail, D=10mm, L=420mm
09120047304464Cannulated Tibia Nail, D=10mm, L=405mm
09120047304457Cannulated Tibia Nail, D=9.0mm, L=420mm
09120047304020Cannulated Tibia Nail, D=10mm, L=375mm
09120047304013Cannulated Tibia Nail, D=10mm, L=300mm
09120047302118Cannulated Tibia Nail, D=10mm, L=390mm
09120047301968Cannulated Tibia Nail, D=9.0mm, L=315mm
09120047301739Cannulated Tibia Nail, D=10mm, L=345mm
09120047301722Cannulated Tibia Nail, D=10mm, L=330mm
09120047301692Cannulated Tibia Nail, D=10mm, L=315mm
09120047301456Cannulated Tibia Nail, D=9.0mm, L=390mm
09120047301449Cannulated Tibia Nail, D=9.0mm, L=375mm
09120047301432Cannulated Tibia Nail, D=9.0mm, L=360mm
09120047301425Cannulated Tibia Nail, D=9.0mm, L=345mm
09120047301418Cannulated Tibia Nail, D=9.0mm, L=330mm
09120047301395Cannulated Tibia Nail, D=10mm, L=285mm
09120047301388Cannulated Tibia Nail, D=9.0mm, L=405mm
09120047301371Cannulated Tibia Nail, D=9.0mm, L=300mm
09120047301364Cannulated Tibia Nail, D=9.0mm, L=285mm
09120047301241Cannulated Tibia Nail, D=10mm, L=360mm

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