Primary Device ID | 09348215117757 |
NIH Device Record Key | a7d7cdc7-c575-438c-98d3-58cef52b5e6d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Patella Drill Guide |
Version Model Number | 122-18-1602 |
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 | 09348215117757 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[09348215117757]
Moist Heat or Steam Sterilization
[09348215117757]
Moist Heat or Steam Sterilization
[09348215117757]
Moist Heat or Steam Sterilization
[09348215117757]
Moist Heat or Steam Sterilization
[09348215117757]
Moist Heat or Steam Sterilization
[09348215117757]
Moist Heat or Steam Sterilization
[09348215117757]
Moist Heat or Steam Sterilization
[09348215117757]
Moist Heat or Steam Sterilization
[09348215117757]
Moist Heat or Steam Sterilization
[09348215117757]
Moist Heat or Steam Sterilization
[09348215117757]
Moist Heat or Steam Sterilization
[09348215117757]
Moist Heat or Steam Sterilization
[09348215117757]
Moist Heat or Steam Sterilization
[09348215117757]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-09-03 |
Device Publish Date | 2025-08-26 |
09348215074166 | 122-15-0448 |
09348215041861 | 122-10-0254 |
09348215041854 | 122-10-0253 |
09348215041847 | 122-10-0252 |
09348215041830 | 122-10-0251 |
09348215117757 | 122-18-1602 |