Home GUDID 07340152100399 OPRA Implant System
Primary DI 07340152100399
Brand OPRA Implant System
Company Integrum AB
Model 1736
Catalog number 1736
Device description OPRA S1 Instrument Kit
Published 2016-03-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name PJY Transfemoral Percutaneous Prosthetic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PJY Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17340152100399 Package GS1 21 In Commercial Distribution 07340152100399 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 17340152100399 17340152100399 07340152100399 07340152100399 7340152100399
GMDN Terms# Term, Definition table Term Definition Internal-external leg prosthesis osseointegration bar A rod with a screw-like or press-fit design intended to be implanted into the residual bone of a lower limb (e.g., femur, tibia) after amputation to function as an anchoring fixture and stabilizing bar for the connection of an internal-external leg prosthesis. It is designed to project beyond the bone but not through the skin so that a protruding trans-stomal connector/abutment can be attached to its distal end to interface with the external prosthesis. It is typically composed of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and has a porous surface intended to improve fixation by promoting bone ingrowth (osseointegration).
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 356739813 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07340152102379 Instrument Kit: Hammer System F/ G Integrum AB PJY 2024-10-15 07340152102386 Instrument Kit: Abutment Screw Adjustment G Integrum AB PJY 2024-10-15 07340152102065 Instrument Kit Marrow Blood Sample Integrum AB PJY 2023-12-18 07340152102119 OPRA™ Implant System Abutment 12x78 +1 Integrum AB PJY 2023-12-18 07340152102126 OPRA™ Implant System Abutment 12x78 +2 Integrum AB PJY 2023-12-18 07340152102133 OPRA™ Implant System Abutment 12x78 +3 Integrum AB PJY 2023-12-18 07340152102140 OPRA™ Implant System Abutment 12x78 +4 Integrum AB PJY 2023-12-18 07340152102157 OPRA™ Implant System Abutment 12x78 +5 Integrum AB PJY 2023-12-18 07340152102164 OPRA™ Implant System Abutment 12x78 +6 Integrum AB PJY 2023-12-18 07340152102171 OPRA™ Implant System Abutment 12x78 +7 Integrum AB PJY 2023-12-18 07340152102188 OPRA™ Implant System Abutment 12x78 +8 Integrum AB PJY 2023-12-18 07340152102195 OPRA™ Implant System Abutment 12x78 +9 Integrum AB PJY 2023-12-18 07340152102201 OPRA™ Implant System Abutment 12x78 +10 Integrum AB PJY 2023-12-18 07340152102218 OPRA™ Implant System Drill-bit 11,7 mm Integrum AB PJY 2023-12-18 07340152101679 Fixture Removal Trephine and Guide Sleeve Kit 16,5 mm Integrum AB PJY 2023-07-28 07340152101686 Fixture Removal Trephine and Guide Sleeve Kit 17 mm Integrum AB PJY 2023-07-28 07340152101693 Fixture Removal Trephine and Guide Sleeve Kit 17,5 mm Integrum AB PJY 2023-07-28 07340152101709 Fixture Removal Trephine and Guide Sleeve Kit 18 mm Integrum AB PJY 2023-07-28 07340152101716 Fixture Removal Trephine and Guide Sleeve Kit 18,5 mm Integrum AB PJY 2023-07-28 07340152101730 Fixture Removal Trephine and Guide Sleeve Kit 19,5 mm Integrum AB PJY 2023-07-28 07340152101747 Fixture Removal Trephine and Guide Sleeve Kit 20 mm Integrum AB PJY 2023-07-28 07340152101754 Fixture Removal Trephine and Guide Sleeve Kit 21 mm Integrum AB PJY 2023-07-28 07340152101761 Fixture Removal Trephine and Guide Sleeve Kit 22 mm Integrum AB PJY 2023-07-28 07340152101778 Fixture Removal Trephine and Guide Sleeve Kit 23 mm Integrum AB PJY 2023-07-28 07340152101785 Fixture Removal Trephine and Guide Sleeve Kit 24 mm Integrum AB PJY 2023-07-28 07340152101792 Fixture Removal Trephine and Guide Sleeve Kit 25 mm Integrum AB PJY 2023-07-28 07340152102027 Instrument Kit: Fractured Abutment/ Screw USA Integrum AB PJY 2023-07-25 07340152101662 Fixture Removal Trephine and Guide Sleeve Kit 16 mm Integrum AB PJY 2023-07-15 07340152101723 Fixture Removal Trephine and Guide Sleeve Kit 19 mm Integrum AB PJY 2023-07-15 07340152102225 Fixture Removal Guide Pins Kit Platform G Integrum AB PJY 2023-07-15
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