Primary Device ID | 09342395002209 |
NIH Device Record Key | ba8ad48a-6d51-4d5c-a82e-ab5c459889a2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tango Reflex Neo |
Version Model Number | Tango Reflex Neo |
Company DUNS | 756138509 |
Company Name | ELLEX MEDICAL 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 | false |
Serial Number | true |
Manufacturing Date | true |
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 | 09342395002209 [Primary] |
HQF | Laser, Ophthalmic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-05-09 |
Device Publish Date | 2023-05-01 |
09342395002278 - 40MHZKIT-USA | 2024-12-04 |
09342395002285 - ACC00042 | 2024-12-04 |
09342395001370 - Eye Cubed V4 New Gen | 2024-10-18 |
09342395000038 - UltraQ | 2024-10-17 |
09342395000069 - Solo | 2024-10-17 |
09342395000113 - Tango | 2024-10-17 |
09342395000137 - UltraQ | 2024-10-17 |
09342395000212 - 2RT | 2024-10-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TANGO REFLEX NEO 79352176 not registered Live/Pending |
Ellex Medical Pty. Ltd. 2022-08-19 |