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

00714646001474 - Pelvis Belly Replacement Leg Cushion2025-08-29 Pelvis Belly Replacement Leg Cushion
00714646001481 - Pelvis Belly Replacement Arm Rest Cushion2025-08-29 Pelvis Belly Replacement Arm Rest Cushion
00714646001498 - Pelvis Belly Replacement Stomach Cushion - Medium2025-08-29 Pelvis Belly Replacement Stomach Cushion - Medium
00714646001504 - Pelvis Belly Replacement Face Cushion Assembly2025-08-29 Pelvis Belly Replacement Face Cushion Assembly
00714646001511 - Pelvis Belly Replacement Stomach Cushion - Small2025-08-29 Pelvis Belly Replacement Stomach Cushion - Small
10714646001099 - Microsuction Stater Pack2025-07-16 Microsuction Starter Pack
10714646001105 - Microsuction Replacement Pack2025-07-16 Microsuction Replacement Pack
10714646001129 - Sample: Opti-Tatt2025-06-30 Opti-Tatt Sample - 2 Dot, 2 Crosshair, 2 Field Border

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