Fixture Removal Trephine and Guide Sleeve Kit 19 mm

GUDID 07340152101723

The fixture removal Trephine is a single use instrument used as a cutting tool that drills (cuts) into the bone around and along the Fixture to enable extraction of the Fixture. The Guide Sleeves are single use instruments. They are used together with the set of guide pins to centre the Trephine around the Fixture when the trephine cuts along the Fixture in the bone.

Integrum AB

Internal-external leg prosthesis osseointegration bar

• Primary Device ID: 07340152101723
• NIH Device Record Key: 8a7961e6-f4cb-4f72-a65e-8b2fc19ea361
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixture Removal Trephine and Guide Sleeve Kit 19 mm
• Version Model Number: 2542
• Company DUNS: 356739813
• Company Name: Integrum AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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	07340152101723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190009

FDA Product Code

• PJY: Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

Sterilization

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

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

[07340152101723]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-24
• Device Publish Date: 2023-07-15

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