Primary Device ID | 10714646000474 |
NIH Device Record Key | cc9a59c6-cdc7-44f0-b015-3967076deb8e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OtoClear Ear Irrigation System Wands |
Version Model Number | 27220 |
Catalog Number | 27220 |
Company DUNS | 117844489 |
Company Name | Bionix, LLC |
Device Count | 3 |
DM Exempt | true |
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 | 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 |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00714646000477 [Primary] |
GS1 | 10714646000474 [Unit of Use] |
LRD | APPLICATOR, ENT DRUG |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-31 |
Device Publish Date | 2023-07-21 |
00714646000606 - Igloo Wound Irrigator | 2024-10-03 Wound Irrigation - Sample |
10714646000665 - ShotBlocker® | 2024-09-26 5 ct ShotBlocker |
10714646000849 - ShotBlocker® | 2024-09-26 ShotBlocker® 2000 ct. Retail |
20714646000860 - SafeStraw™ 2 Pack | 2024-09-26 SafeStraw™ 2 Pack |
10714646000993 - Opti-Tatt™ Dots | 2024-09-26 Opti-Tatt, Dot, Sheet of 24 |
10714646001006 - Opti-Tatt™ Crosshairs | 2024-09-26 Opti-Tatt, Crosshair, Sheet of 24 |
10714646001013 - Opti-Tatt™ Field Borders | 2024-09-26 Opti-Tatt, Field Border, Sheet of 24 |
10714646001020 - Sample: Opti-Tatt Dots | 2024-09-26 Sample: Opti-Tatt, Dot, Sheet of 3 |