Cortical Screw, Locking 37351-40-N

GUDID 09120034305078

Cortical Screw, Locking, D=3.5mm, L=40mm, SH

I.T.S. GmbH

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 09120034305078
• NIH Device Record Key: 3cbb4b05-e426-4c9e-b464-fd1216788630
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cortical Screw, Locking
• Version Model Number: 37351-40-N
• Catalog Number: 37351-40-N
• Company DUNS: 303456917
• Company Name: I.T.S. GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120034305078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063166

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

[09120034305078]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-08
• Device Publish Date: 2016-09-02

On-Brand Devices [Cortical Screw, Locking]

• 09120069812770: Cortical Screw, Locking, D=3.5mm, L=120mm, SH
• 09120069812763: Cortical Screw, Locking, D=3.5mm, L=115mm, SH
• 09120069812756: Cortical Screw, Locking, D=3.5mm, L=110mm, SH
• 09120069812749: Cortical Screw, Locking, D=3.5mm, L=105mm, SH
• 09120069812732: Cortical Screw, Locking, D=3.5mm, L=100mm, SH
• 09120069812725: Cortical Screw, Locking, D=3.5mm, L=95mm, SH
• 09120069812718: Cortical Screw, Locking, D=3.5mm, L=90mm, SH
• 09120069812701: Cortical Screw, Locking, D=3.5mm, L=85mm, SH
• 09120069812695: Cortical Screw, Locking, D=3.5mm, L=80mm, SH
• 09120069812688: Cortical Screw, Locking, D=3.5mm, L=75mm, SH
• 09120069812671: Cortical Screw, Locking, D=3.5mm, L=70mm, SH
• 09120069812664: Cortical Screw, Locking, D=3.5mm, L=65mm, SH
• 09120069812657: Cortical Screw, Locking, D=3.5mm, L=60mm, SH
• 09120069812640: Cortical Screw, Locking, D=3.5mm, L=55mm, SH
• 09120069812633: Cortical Screw, Locking, D=3.5mm, L=50mm, SH
• 09120069812626: Cortical Screw, Locking, D=3.5mm, L=48mm, SH
• 09120069812619: Cortical Screw, Locking, D=3.5mm, L=46mm, SH
• 09120069812602: Cortical Screw, Locking, D=3.5mm, L=44mm, SH
• 09120069812596: Cortical Screw, Locking, D=3.5mm, L=42mm, SH
• 09120069811896: Cortical Screw, Locking, D=3.5mm, L=10mm, SH
• 09120047297933: Cortical Screw, Locking, D=3.5mm, L=38mm, SH
• 09120047297926: Cortical Screw, Locking, D=3.5mm, L=26mm, SH
• 09120047297919: Cortical Screw, Locking, D=3.5mm, L=34mm, SH
• 09120047295236: Cortical Screw, Locking, D=3.5mm, L=22mm, SH
• 09120047295229: Cortical Screw, Locking, D=3.5mm, L=20mm, SH
• 09120047295212: Cortical Screw, Locking, D=3.5mm, L=18mm, SH
• 09120047295205: Cortical Screw, Locking, D=3.5mm, L=16mm, SH
• 09120047295199: Cortical Screw, Locking, D=3.5mm, L=14mm, SH
• 09120047295182: Cortical Screw, Locking, D=3.5mm, L=12mm, SH
• 09120034307966: Cortical Screw, Locking, D=3.5mm, L=30mm, SH
• 09120034307201: Cortical Screw, Locking, D=4.5mm, L=120mm
• 09120034307195: Cortical Screw, Locking, D=4.5mm, L=115mm
• 09120034307188: Cortical Screw, Locking, D=4.5mm, L=110mm
• 09120034307171: Cortical Screw, Locking, D=4.5mm, L=105mm
• 09120034307164: Cortical Screw, Locking, D=4.5mm, L=100mm
• 09120034307157: Cortical Screw, Locking, D=4.5mm, L=95mm
• 09120034307027: Cortical Screw, Locking, D=4.5mm, L=90mm
• 09120034307010: Cortical Screw, Locking, D=4.5mm, L=85mm
• 09120034307003: Cortical Screw, Locking, D=4.5mm, L=80mm
• 09120034306990: Cortical Screw, Locking, D=4.5mm, L=75mm
• 09120034306983: Cortical Screw, Locking, D=4.5mm, L=70mm
• 09120034306976: Cortical Screw, Locking, D=4.5mm, L=65mm
• 09120034306969: Cortical Screw, Locking, D=4.5mm, L=60mm
• 09120034306952: Cortical Screw, Locking, D=4.5mm, L=56mm
• 09120034306945: Cortical Screw, Locking, D=4.5mm, L=52mm
• 09120034306938: Cortical Screw, Locking, D=4.5mm, L=48mm
• 09120034306921: Cortical Screw, Locking, D=4.5mm, L=44mm
• 09120034306914: Cortical Screw, Locking, D=4.5mm, L=40mm
• 09120034306907: Cortical Screw, Locking, D=4.5mm, L=36mm
• 09120034306891: Cortical Screw, Locking, D=4.5mm, L=32mm