| Primary Device ID | 09348215041830 |
| NIH Device Record Key | 7d15381c-721e-4901-8b98-56e0d41f6ffb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Patella Drill Guide |
| Version Model Number | 122-10-0251 |
| Company DUNS | 751993028 |
| Company Name | SIGNATURE ORTHOPAEDICS PTY LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 09348215041830 [Primary] |
| MDM | Instrument, Manual, Surgical, General Use |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[09348215041830]
Moist Heat or Steam Sterilization
[09348215041830]
Moist Heat or Steam Sterilization
[09348215041830]
Moist Heat or Steam Sterilization
[09348215041830]
Moist Heat or Steam Sterilization
[09348215041830]
Moist Heat or Steam Sterilization
[09348215041830]
Moist Heat or Steam Sterilization
[09348215041830]
Moist Heat or Steam Sterilization
[09348215041830]
Moist Heat or Steam Sterilization
[09348215041830]
Moist Heat or Steam Sterilization
[09348215041830]
Moist Heat or Steam Sterilization
[09348215041830]
Moist Heat or Steam Sterilization
[09348215041830]
Moist Heat or Steam Sterilization
[09348215041830]
Moist Heat or Steam Sterilization
[09348215041830]
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 | 2018-10-09 |
| 09348215074166 | 122-15-0448 |
| 09348215041861 | 122-10-0254 |
| 09348215041854 | 122-10-0253 |
| 09348215041847 | 122-10-0252 |
| 09348215041830 | 122-10-0251 |
| 09348215117757 | 122-18-1602 |