Fixation Screw 118003-7

GUDID 09120047297254

Fixation Screw, Distal Femur Plate

I.T.S. GmbH

Orthopaedic implant aiming arm
Primary Device ID09120047297254
NIH Device Record Keye7eada67-c6fd-4696-841e-28d383d83ea5
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixation Screw
Version Model Number118003-7
Catalog Number118003-7
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 Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109120047297254 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


[09120047297254]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-08-09
Device Publish Date2018-10-19

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.