Primary Device ID | 09348215080891 |
NIH Device Record Key | c8f945b2-81b7-4a17-a594-6fe5477ee390 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Fusion Taper Sleeve Remover Collett |
Version Model Number | 112-32-0236 |
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 | 09348215080891 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[09348215080891]
Moist Heat or Steam Sterilization
[09348215080891]
Moist Heat or Steam Sterilization
[09348215080891]
Moist Heat or Steam Sterilization
[09348215080891]
Moist Heat or Steam Sterilization
[09348215080891]
Moist Heat or Steam Sterilization
[09348215080891]
Moist Heat or Steam Sterilization
[09348215080891]
Moist Heat or Steam Sterilization
[09348215080891]
Moist Heat or Steam Sterilization
[09348215080891]
Moist Heat or Steam Sterilization
[09348215080891]
Moist Heat or Steam Sterilization
[09348215080891]
Moist Heat or Steam Sterilization
[09348215080891]
Moist Heat or Steam Sterilization
[09348215080891]
Moist Heat or Steam Sterilization
[09348215080891]
Moist Heat or Steam Sterilization
[09348215080891]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-05-03 |
Device Publish Date | 2021-04-23 |
09348215068608 - Marker Pin Inserter | 2024-09-11 |
09348215068646 - Cap Inserter | 2024-09-11 |
09348215068677 - Screw Inserter | 2024-09-11 |
09348215069209 - T-Bar Screw Inserter | 2024-09-11 |
09348215129224 - Verteloc Lumbar Cage | 2024-03-20 |
09348215129231 - Verteloc Lumbar Cage | 2024-03-20 |
09348215129248 - Verteloc Lumbar Cage | 2024-03-20 |
09348215129255 - Verteloc Lumbar Cage | 2024-03-20 |