OPRA Implant System IBC0009

GUDID 07340152100412

Fixture 16,5x80

Integrum AB

Internal-external leg prosthesis osseointegration bar
Primary Device ID07340152100412
NIH Device Record Key0230f953-5cd5-42e7-829c-c39a72ca4512
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPRA Implant System
Version Model NumberIBC0009
Catalog NumberIBC0009
Company DUNS356739813
Company NameIntegrum AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+46317601060
Emailinfo@integrum.se

Device Identifiers

Device Issuing AgencyDevice ID
GS107340152100412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PJYTransfemoral Percutaneous Prosthetic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07340152100412]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-05
Device Publish Date2016-03-29

On-Brand Devices [OPRA Implant System]

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

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