Sample, Safe Ear Curette Rainbow Pack 25777-9

GUDID 10714646000566

Sample, Safe Ear Curette Rainbow Pack

Bionix, LLC

Endaural wax extraction curette
Primary Device ID10714646000566
NIH Device Record Key25558684-1b2f-4909-ae61-cab017e4e7cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSample, Safe Ear Curette Rainbow Pack
Version Model Number25777-9
Catalog Number25777-9
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
GS100714646000569 [Primary]
GS110714646000566 [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

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.