| Primary Device ID | 09351327000695 |
| NIH Device Record Key | bea2cfed-145f-4c18-9701-d169daf57996 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPS |
| Version Model Number | 1248-0072 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 09351327000695 [Primary] |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09351327000695]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-25 |
| Device Publish Date | 2020-02-17 |
| 09351327000831 | Impactor Canister Dual Adaptor |
| 09351327000824 | Curved Guide Handle Post |
| 09351327000817 | Curved Guide Handle |
| 09351327000688 | Reamer Adaptor Stryker |
| 09351327000671 | Canister Clamp |
| 09351327000664 | Reference Post |
| 09351327000800 | T-Handle Hex Key |
| 09351327000770 | Impactor Canister Adaptor 45mm |
| 09351327000763 | Short Curved Guide Handle Screwdriver |
| 09351327000756 | Short Curved Guide Handle Screw |
| 09351327000749 | Long Curved Guide Handle |
| 09351327000732 | Short Curved Guide Handle |
| 09351327000725 | Reference Arm Long |
| 09351327000718 | Reference Arm Short |
| 09351327000701 | Right Angle Clamp |
| 09351327000695 | Impactor Canister Adaptor 42.5mm |