OPRA Implant System 1341

GUDID 07340152100047

Fixture BioHelix 17,5x80

Integrum AB

Internal-external leg prosthesis osseointegration bar

• Primary Device ID: 07340152100047
• NIH Device Record Key: 7f7cd2e5-562b-46cf-acc4-5aad0a407b57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPRA Implant System
• Version Model Number: 1341
• Catalog Number: 1341
• 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: false
• Lot Batch: true
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +46317601060
• Email: info@integrum.se

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340152100047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H080004

FDA Product Code

• PJY: Transfemoral Percutaneous Prosthetic

Sterilization

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

[07340152100047]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2016-03-04

On-Brand Devices [OPRA Implant System]

• 07340152101549: Soft Tissue Support Mould Large
• 07340152101532: Soft Tissue Support Mould Small
• 07340152101525: Abutment Screw Diamond 87mm
• 07340152101518: Abutment Screw Diamond 82
• 07340152101501: Left Drill Ø2,5 mm Short Tip
• 07340152101495: Torx
• 07340152101488: Thread tap M9mm
• 07340152101471: Drill-bit 10,9 mm
• 07340152101464: Drill-bit 10,7 mm
• 07340152101457: Drill-bit 8,3 mm
• 07340152101440: Drill 7mm with Entrance
• 07340152101433: OPRA Abutment X 77+10
• 07340152101426: OPRA Abutment X 77+9
• 07340152101419: OPRA Abutment X 77+8
• 07340152101402: OPRA Abutment X 77+7
• 07340152101396: OPRA Abutment X 77+6
• 07340152101389: OPRA S2 Instrument Kit Humerus/Femur
• 07340152101372: OPRA S1 Instrument Kit Humerus/Femur
• 07340152101365: Axor II Kit
• 07340152101358: Axor II Service Kit
• 07340152101341: Soft Tissue Support Pylon
• 07340152101334: Abutment Screw E/F Humerus
• 07340152101327: Abutment F Humerus
• 07340152101310: Abutment E
• 07340152101303: Axor Extension Plate 20 mm
• 07340152101297: Axor Extension Plate 10 mm
• 07340152101280: Axor Extension Plate 5 mm
• 07340152101273: Soft Tissue Support Plate Large
• 07340152101266: Soft Tissue Support Plate Small
• 07340152101259: Soft Tissue Support Pylon II
• 07340152101242: Connector
• 17340152101232: OPRA S2 Instrument Kit
• 07340152101228: Abutment Screw 82
• 07340152101211: Abutment Screw 87
• 07340152101204: Abutment Support F
• 07340152101198: Abutment Support E
• 07340152101181: Rotation Safety Device
• 07340152101129: OPRA Abutment X 77
• 07340152101013: Abutment X 72
• 07340152100825: Fixture BioHelix 9x40
• 07340152100818: Fixture BioHelix 8x40
• 07340152100801: Fixture BioHelix 8x20
• 07340152100795: Fixture BioHelix 7x20
• 07340152100788: Fixture BioHelix 6x20
• 07340152100771: Fixture BioHelix 5x15
• 07340152100764: Healing Washer 21x10 mm
• 07340152100757: Healing Washer 21x5 mm
• 07340152100740: Healing Washer 17x10 mm
• 07340152100726: Abutment 12x78
• 07340152100719: Abutment Screw Diamond 87 mm