SprayWash Adapter Wand 27221

GUDID 00714646001177

SprayWash Adapter Wand (Tolco Trigger Sprayer)

Bionix, LLC

Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable Ear canal irrigation kit, reusable
Primary Device ID00714646001177
NIH Device Record Key4c8a53b9-2ffc-4d7d-9033-ec187e1fe9fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSprayWash Adapter Wand
Version Model Number27221
Catalog Number27221
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100714646001177 [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 Date2023-08-17
Device Publish Date2023-08-09

Devices Manufactured by Bionix, LLC

00714646001252 - Lighted Articulating - Sample2024-06-24 Lighted Articulating Curette - Sample
10714646001198 - SecureFoam2024-06-10 SecureFoam - Small
10714646001204 - SecureFoam2024-06-10 SecureFoam - Medium
10714646001211 - SecureFoam2024-06-10 SecureFoam - Large
10714646001228 - SecureFoam2024-06-10 SecureFoam - SAMPLE Small
10714646001235 - SecureFoam2024-06-10 SecureFoam - SAMPLE Medium
10714646001242 - SecureFoam2024-06-10 SecureFoam - SAMPLE Large Box
00714646000101 - T-Form SecureVac Box Adaptor2024-05-20 T-Form SecureVac Box Adaptor

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.