Lighted Ear Curette Demo Pack 22200

GUDID 10714646000542

Lighted Ear Curette Demo Pack

Bionix, LLC

ENT illuminating foreign body extraction set
Primary Device ID10714646000542
NIH Device Record Key03c1c294-ddcd-4cd2-8d8d-4099b4a5f6f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameLighted Ear Curette Demo Pack
Version Model Number22200
Catalog Number22200
Company DUNS117844489
Company NameBionix, LLC
Device Count7
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100714646000545 [Primary]
GS110714646000542 [Unit of Use]

FDA Product Code

JYGCURETTE, EAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-18
Device Publish Date2024-07-10

Devices Manufactured by Bionix, LLC

00714646000606 - Igloo Wound Irrigator2024-10-03 Wound Irrigation - Sample
10714646000665 - ShotBlocker®2024-09-26 5 ct ShotBlocker
10714646000849 - ShotBlocker®2024-09-26 ShotBlocker® 2000 ct. Retail
20714646000860 - SafeStraw™ 2 Pack2024-09-26 SafeStraw™ 2 Pack
10714646000993 - Opti-Tatt™ Dots2024-09-26 Opti-Tatt, Dot, Sheet of 24
10714646001006 - Opti-Tatt™ Crosshairs2024-09-26 Opti-Tatt, Crosshair, Sheet of 24
10714646001013 - Opti-Tatt™ Field Borders2024-09-26 Opti-Tatt, Field Border, Sheet of 24
10714646001020 - Sample: Opti-Tatt Dots2024-09-26 Sample: Opti-Tatt, Dot, Sheet of 3

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