Fixation Screw 118002-7

GUDID 09120047297117

Fixation Screw, Proximal Lateral Tibia Plate

I.T.S. GmbH

Orthopaedic implant aiming arm
Primary Device ID09120047297117
NIH Device Record Keyd264d027-36f3-42fe-b104-3b7b9e77eead
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixation Screw
Version Model Number118002-7
Catalog Number118002-7
Company DUNS303456917
Company NameI.T.S. GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109120047297117 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


[09120047297117]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-08-09
Device Publish Date2018-10-18

On-Brand Devices [Fixation Screw]

09120047297254Fixation Screw, Distal Femur Plate
09120047297117Fixation Screw, Proximal Lateral Tibia Plate
09120047301951Fixation Screw, Hallux Osteotomy Plate
09120047306345Fixation Screw, PRS RXsystem
09120047290026Fixation Screw, PRS upgrade system

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