Epiphysis Screw 38651-80

GUDID 09120034300806

Epiphysis Screw, D=6.5mm, L=80mm, 10mm Thread

I.T.S. GmbH

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 09120034300806
• NIH Device Record Key: 5fcd9172-54fd-4b38-94b8-2a9b7acc43f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epiphysis Screw
• Version Model Number: 38651-80
• Catalog Number: 38651-80
• 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	09120034300806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043410

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

Moist Heat or Steam Sterilization

[09120034300806]

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: 2016-09-12

On-Brand Devices [Epiphysis Screw]

• 09120034300912: Epiphysis Screw, D=6.5mm, L=100mm, 10mm Thread
• 09120034300905: Epiphysis Screw, D=6.5mm, L=105mm, 10mm Thread
• 09120034300899: Epiphysis Screw, D=6.5mm, L=110mm, 10mm Thread
• 09120034300882: Epiphysis Screw, D=6.5mm, L=115mm, 10mm Thread
• 09120034300875: Epiphysis Screw, D=6.5mm, L=120mm, 10mm Thread
• 09120034300868: Epiphysis Screw, D=6.5mm, L=50mm, 10mm Thread
• 09120034300851: Epiphysis Screw, D=6.5mm, L=55mm, 10mm Thread
• 09120034300844: Epiphysis Screw, D=6.5mm, L=60mm, 10mm Thread
• 09120034300837: Epiphysis Screw, D=6.5mm, L=65mm, 10mm Thread
• 09120034300820: Epiphysis Screw, D=6.5mm, L=70mm, 10mm Thread
• 09120034300813: Epiphysis Screw, D=6.5mm, L=75mm, 10mm Thread
• 09120034300806: Epiphysis Screw, D=6.5mm, L=80mm, 10mm Thread
• 09120034300790: Epiphysis Screw, D=6.5mm, L=85mm, 10mm Thread
• 09120034300783: Epiphysis Screw, D=6.5mm, L=90mm, 10mm Thread
• 09120034300776: Epiphysis Screw, D=6.5mm, L=95mm, 10mm Thread