| Primary Device ID | 09348215046248 |
| NIH Device Record Key | d3851c56-9b67-4afc-9419-09e5bccb9611 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adjustable Rotator Setter |
| Version Model Number | 122-16-0386 |
| Company DUNS | 751993028 |
| Company Name | SIGNATURE ORTHOPAEDICS 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 | false |
| 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 | 09348215046248 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09348215046248]
Moist Heat or Steam Sterilization
[09348215046248]
Moist Heat or Steam Sterilization
[09348215046248]
Moist Heat or Steam Sterilization
[09348215046248]
Moist Heat or Steam Sterilization
[09348215046248]
Moist Heat or Steam Sterilization
[09348215046248]
Moist Heat or Steam Sterilization
[09348215046248]
Moist Heat or Steam Sterilization
[09348215046248]
Moist Heat or Steam Sterilization
[09348215046248]
Moist Heat or Steam Sterilization
[09348215046248]
Moist Heat or Steam Sterilization
[09348215046248]
Moist Heat or Steam Sterilization
[09348215046248]
Moist Heat or Steam Sterilization
[09348215046248]
Moist Heat or Steam Sterilization
[09348215046248]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-05-03 |
| Device Publish Date | 2019-02-18 |