Cortical Stabilization Screw 37304-18

GUDID 09120047295113

Cortical Stabilization Screw, D=3.0mm, L=18mm, RH

I.T.S. GmbH

Orthopaedic bone screw (non-sliding)
Primary Device ID09120047295113
NIH Device Record Key0d87466c-e6ed-4d5f-bea6-f8c46901f0a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCortical Stabilization Screw
Version Model Number37304-18
Catalog Number37304-18
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
GS109120047295113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


[09120047295113]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-08
Device Publish Date2016-09-01

On-Brand Devices [Cortical Stabilization Screw]

09120047302101Cortical Stabilization Screw, D=3.0mm, L=7mm, RH
09120047302095Cortical Stabilization Screw, D=3.0mm, L=6mm, RH
09120047299456Cortical Stabilization Screw, D=3.0mm, L=11mm, RH
09120047299449Cortical Stabilization Screw, D=3.0mm, L=9mm, RH
09120047297964Cortical Stabilization Screw, D=3.0mm, L=8mm, RH
09120047295175Cortical Stabilization Screw, D=3.0mm, L=30mm, RH
09120047295168Cortical Stabilization Screw, D=3.0mm, L=28mm, RH
09120047295151Cortical Stabilization Screw, D=3.0mm, L=26mm, RH
09120047295144Cortical Stabilization Screw, D=3.0mm, L=24mm, RH
09120047295137Cortical Stabilization Screw, D=3.0mm, L=22mm, RH
09120047295120Cortical Stabilization Screw, D=3.0mm, L=20mm, RH
09120047295113Cortical Stabilization Screw, D=3.0mm, L=18mm, RH
09120047295106Cortical Stabilization Screw, D=3.0mm, L=16mm, RH
09120047295090Cortical Stabilization Screw, D=3.0mm, L=14mm, RH
09120047293829Cortical Stabilization Screw, D=3.0mm, L=12mm, RH
09120047293812Cortical Stabilization Screw, D=3.0mm, L=10mm, RH

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