Primary Device ID | 00714646000675 |
NIH Device Record Key | fb481b45-a8e3-4e65-a1e5-1fdb662384bd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ear Wax Removal Kit 12 Ct. Case |
Version Model Number | 704 |
Catalog Number | 704 |
Company DUNS | 117844489 |
Company Name | Bionix, LLC |
Device Count | 12 |
DM Exempt | true |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
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 | true |
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 | |
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 | |
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 | 00714646000675 [Unit of Use] |
GS1 | 10714646000672 [Primary] |
OGQ | Ear irrigation kit |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-11-04 |
Device Publish Date | 2022-10-27 |
10714646000788 - SutureOut | 2024-05-01 SutureOut, 50ct |
10714646001181 - SutureOut | 2024-05-01 SutureOut, 3ct Sample |
10714646000771 - ShotBlocker | 2024-03-25 ShotBlocker 1,000 ct |
00714646000804 - AlphaCleanse® Antimicrobial Wound Care System | 2024-01-08 AlphaCleanse® Antimicrobial Wound Care System |
20859911004768 - ShotBlocker® | 2023-10-06 ShotBlocker 50ct |
10859911004778 - ShotBlocker® | 2023-10-06 ShotBlocker 100ct |
10714646001136 - ClearLook Lighted AngleLoop | 2023-08-21 ClearLook Lighted AngleLoop, 50 curettes |
10714646001143 - ClearLook Lighted MicroLoop | 2023-08-21 ClearLook Lighted MicroLoop, 50 curettes |