OPRA™ Implant System Drill-bit 11,7 mm

GUDID 07340152102218

Drill-bit 11,7 mm

Integrum AB

Internal-external leg prosthesis osseointegration bar

• Primary Device ID: 07340152102218
• NIH Device Record Key: d72a9408-b32b-4096-8d46-0bd652e29525
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPRA™ Implant System Drill-bit 11,7 mm
• Version Model Number: 2590
• 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: false
• Expiration Date: true
• 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	07340152102218 [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: true

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

[07340152102218]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-26
• Device Publish Date: 2023-12-18

Devices Manufactured by Integrum AB

• 07340152102379 - Instrument Kit: Hammer System F/ G: 2024-10-23 Surgical Instrument Kit Hammer System
• 07340152102386 - Instrument Kit: Abutment Screw Adjustment G: 2024-10-23 Surgical Instrument Kit for Abutment Screw adjustment.
• 07340152102065 - Instrument Kit Marrow Blood Sample: 2023-12-26 Instrument Kit for Marrow Blood Sample OPRA™ Implant System
• 07340152102119 - OPRA™ Implant System Abutment 12x78 +1: 2023-12-26 Abutment 12x78 +1
• 07340152102126 - OPRA™ Implant System Abutment 12x78 +2: 2023-12-26 Abutment 12x78 +2
• 07340152102133 - OPRA™ Implant System Abutment 12x78 +3: 2023-12-26 Abutment 12x78 +3
• 07340152102140 - OPRA™ Implant System Abutment 12x78 +4: 2023-12-26 Abutment 12x78 +4
• 07340152102157 - OPRA™ Implant System Abutment 12x78 +5: 2023-12-26 Abutment 12x78 +5