Primary Device ID | 09348215068349 |
NIH Device Record Key | 06514911-3d31-43bb-a4de-6c3745c7b09b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Awl |
Version Model Number | 132-19-0001 |
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 | 09348215068349 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[09348215068349]
Moist Heat or Steam Sterilization
[09348215068349]
Moist Heat or Steam Sterilization
[09348215068349]
Moist Heat or Steam Sterilization
[09348215068349]
Moist Heat or Steam Sterilization
[09348215068349]
Moist Heat or Steam Sterilization
[09348215068349]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2022-06-10 |
Device Publish Date | 2020-06-11 |
09348215066895 | 132-16-0010 |
09348215066314 | PS2-08-0010 |
09348215068349 | 132-19-0001 |
09348215068332 | 132-19-0001 |
09348215039493 | 132-19-0022 |