| Primary Device ID | 07340152101464 |
| NIH Device Record Key | c39c52f0-2bb1-4e18-b33c-49b76091d71f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPRA Implant System |
| Version Model Number | 1611 |
| 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 |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se | |
| Phone | +46317601060 |
| info@integrum.se |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07340152101464 [Primary] |
| PJY | Transfemoral Percutaneous Prosthetic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
[07340152101464]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2018-01-26 |
| 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 |