Primary Device ID | 09351327000060 |
NIH Device Record Key | 5198be01-ffed-4618-9eef-1aeffb302fa8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral |
Version Model Number | 1248-1500, 1248-1700, 1250-1100,1250-1200 |
Company DUNS | 745735175 |
Company Name | OPTIMIZED ORTHO PTY LTD |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 09351327000060 [Primary] |
PBF | Orthopaedic Surgical Planning And Instrument Guides |
Steralize Prior To Use | true |
Device Is Sterile | false |
[09351327000060]
Moist Heat or Steam Sterilization
[09351327000060]
Moist Heat or Steam Sterilization
[09351327000060]
Moist Heat or Steam Sterilization
[09351327000060]
Moist Heat or Steam Sterilization
[09351327000060]
Moist Heat or Steam Sterilization
[09351327000060]
Moist Heat or Steam Sterilization
[09351327000060]
Moist Heat or Steam Sterilization
[09351327000060]
Moist Heat or Steam Sterilization
[09351327000060]
Moist Heat or Steam Sterilization
[09351327000060]
Moist Heat or Steam Sterilization
[09351327000060]
Moist Heat or Steam Sterilization
[09351327000060]
Moist Heat or Steam Sterilization
[09351327000060]
Moist Heat or Steam Sterilization
[09351327000060]
Moist Heat or Steam Sterilization
[09351327000060]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-04-26 |
Device Publish Date | 2019-04-18 |
09351327001302 - Optimized Ortho Positioning (OPS) System | 2022-06-03 OPS Reusable Instrument Inner Tray |
09351327001364 - Optimized Ortho Positioning (OPS) System | 2022-06-03 OPS Reusable Instrument Outer Tray with Lid |
09351327000848 - OPSInsight™ | 2021-03-24 OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, |
09351327000695 - OPS | 2020-02-25 Impactor Canister Adaptor 42.5mm |
09351327000701 - OPS | 2020-02-25 Right Angle Clamp |
09351327000718 - OPS | 2020-02-25 Reference Arm Short |
09351327000725 - OPS | 2020-02-25 Reference Arm Long |
09351327000732 - OPS | 2020-02-25 Short Curved Guide Handle |