OPRA™ Implant System Abutment 12x78 +3

GUDID 07340152102133

Abutment 12x78 +3

Integrum AB

Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar Internal-external leg prosthesis osseointegration bar

• Primary Device ID: 07340152102133
• NIH Device Record Key: 718f3025-b0b8-404f-a933-0b2bac9837df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPRA™ Implant System Abutment 12x78 +3
• Version Model Number: 2593
• Company DUNS: 356739813
• Company Name: Integrum AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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	07340152102133 [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

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

Radiation Sterilization

[07340152102133]

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

• 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: 2023-12-26Abutment 12x78 +3
• 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
• 07340152102164 - OPRA™ Implant System Abutment 12x78 +6: 2023-12-26 Abutment 12x78 +6
• 07340152102171 - OPRA™ Implant System Abutment 12x78 +7: 2023-12-26 Abutment 12x78 +7