Primary Device ID | 09348215152680 |
NIH Device Record Key | f7ea6785-197d-48df-a82e-522137e9d090 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Proximal Reamer Ø13 |
Version Model Number | 111-552-423 |
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 | 09348215152680 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[09348215152680]
Moist Heat or Steam Sterilization
[09348215152680]
Moist Heat or Steam Sterilization
[09348215152680]
Moist Heat or Steam Sterilization
[09348215152680]
Moist Heat or Steam Sterilization
[09348215152680]
Moist Heat or Steam Sterilization
[09348215152680]
Moist Heat or Steam Sterilization
[09348215152680]
Moist Heat or Steam Sterilization
[09348215152680]
Moist Heat or Steam Sterilization
[09348215152680]
Moist Heat or Steam Sterilization
[09348215152680]
Moist Heat or Steam Sterilization
[09348215152680]
Moist Heat or Steam Sterilization
[09348215152680]
Moist Heat or Steam Sterilization
[09348215152680]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2025-10-07 |
Device Publish Date | 2025-09-16 |
09348215152673 - Proximal Reamer Ø12 | 2025-10-07 |
09348215152680 - Proximal Reamer Ø13 | 2025-10-07 |
09348215152680 - Proximal Reamer Ø13 | 2025-10-07 |
09348215148898 - Rx Knee Femoral Box Cut Guide Size 1 - 2 | 2025-09-04 |
09348215148904 - Rx Knee Femoral Box Cut Guide Size 3 - 4 | 2025-09-04 |
09348215148911 - Rx Knee Femoral Box Cut Guide Size 5- 6 | 2025-09-04 |
09348215148928 - Rx Knee Femoral Box Cut Guide Size 7 - 8 | 2025-09-04 |
09348215148935 - Rx Knee Femoral Box Cut Guide Size 9 - 9 | 2025-09-04 |
09348215117658 - Patella Sizer | 2025-09-03 |