OtoClear SprayWash Adapter Wand 27219

GUDID 00859911004818

SprayWash Adapter Wand

Bionix, LLC

Ear canal irrigation kit, reusable
Primary Device ID00859911004818
NIH Device Record Key2eafa4e9-431c-458f-811a-6fb94d4f5b8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOtoClear SprayWash Adapter Wand
Version Model Number27219
Catalog Number27219
Company DUNS117844489
Company NameBionix, LLC
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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-Counterfalse

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100859911004818 [Primary]

FDA Product Code

KCPSYRINGE, ENT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-31
Device Publish Date2023-07-21

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.