Ear Wax Removal Kit 12 Ct. Case 704

GUDID 00714646000675

Ear Wax Removal Kit 12 Ct. Case

Bionix, LLC

Ear canal irrigation kit, single-use
Primary Device ID00714646000675
NIH Device Record Keyfb481b45-a8e3-4e65-a1e5-1fdb662384bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameEar Wax Removal Kit 12 Ct. Case
Version Model Number704
Catalog Number704
Company DUNS117844489
Company NameBionix, LLC
Device Count12
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100714646000675 [Unit of Use]
GS110714646000672 [Primary]

FDA Product Code

OGQEar irrigation kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-04
Device Publish Date2022-10-27

Devices Manufactured by Bionix, LLC

00714646001283 - Suture Removal Kit2025-03-20 Suture Removal Kit - 50ct case
10714646001303 - ClearLook Lighted AngleLoop, Refill2025-03-05 ClearLook Lighted AngleLoop, 50ct Refill
10714646001310 - ClearLook Lighted MicroLoop, Refill2025-03-05 ClearLook Lighted MicroLoop, 50ct Refill
10714646001327 - ClearLook Lighted VersaLoop, Refill2025-03-05 ClearLook Lighted VersaLoop, 50ct Refill
10714646001334 - ClearLook Lighted FlexLoop, Refill2025-03-05 ClearLook Lighted FlexLoop, 50ct Refill
10714646001341 - ClearLook Lighted Variety Pack, Refill2025-03-05 ClearLook Lighted Variety Pack, 50ct Refill
10714646001358 - ClearLook Lighted InfantScoop, Refill2025-03-05 ClearLook Lighted InfantScoop, 50ct Refill
10714646001365 - ClearLook Lighted Variety Pack with Rechargeable Light Source2025-03-05 ClearLook Lighted Variety Pack with Rechargeable Light Source

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.