Endcap, +10mm 118008-12

GUDID 09120047301807

Endcap, +10mm, Cannulated Tibia Nail

I.T.S. GmbH

Orthopaedic implant aiming arm
Primary Device ID09120047301807
NIH Device Record Key9a2c4916-342a-4108-bc6f-fc68de9714b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndcap, +10mm
Version Model Number118008-12
Catalog Number118008-12
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
GS109120047301807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


[09120047301807]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-09
Device Publish Date2016-09-14

On-Brand Devices [Endcap, +10mm]

09120047303108Endcap, +10mm, Cannulated Femur Nail
09120047301807Endcap, +10mm, Cannulated Tibia Nail

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