OtoClear Ear Irrigation Tips 7200ST

GUDID 10714646000702

OtoClear Tips, 5000 ct

Bionix, LLC

Ear canal irrigation tip
Primary Device ID10714646000702
NIH Device Record Key71f86378-d94c-47d9-9a35-c66725babac0
Commercial Distribution StatusIn Commercial Distribution
Brand NameOtoClear Ear Irrigation Tips
Version Model Number7200ST
Catalog Number7200ST
Company DUNS117844489
Company NameBionix, LLC
Device Count5000
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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-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
GS100714646000705 [Primary]
GS110714646000702 [Unit of Use]

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

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10714646000641 - Lighted Ear Curette Demo Pack (monthly mailer)2024-07-18 Lighted Ear Curette Demo Pack (monthly mailer)
00714646001085 - Sample, Lighted Suction Handle2024-07-18 Sample, Lighted Suction Handle
00714646001252 - Lighted Articulating - Sample2024-06-24 Lighted Articulating Curette - Sample
10714646001198 - SecureFoam2024-06-10 SecureFoam - Small
10714646001204 - SecureFoam2024-06-10 SecureFoam - Medium

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