Endcap, Standard 118008-10

GUDID 09120047301746

Endcap, Standard, Cannulated Tibia Nail

I.T.S. GmbH

Orthopaedic implant aiming arm

• Primary Device ID: 09120047301746
• NIH Device Record Key: d791bc4b-6b1f-47b9-b3c5-3bc7e11e1446
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endcap, Standard
• Version Model Number: 118008-10
• Catalog Number: 118008-10
• 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	09120047301746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132945

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

[09120047301746]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-09
• Device Publish Date: 2016-09-14

On-Brand Devices [Endcap, Standard]

• 09120047303085: Endcap, Standard, Cannulated Femur Nail
• 09120047301746: Endcap, Standard, Cannulated Tibia Nail