ClearLook Lighted Variety Pack, Refill 3445

GUDID 10714646001341

ClearLook Lighted Variety Pack, 50ct Refill

Bionix, LLC

ENT illuminating foreign body extraction set
Primary Device ID10714646001341
NIH Device Record Keydf6337a6-422d-4e0f-9d61-081b93837e44
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearLook Lighted Variety Pack, Refill
Version Model Number3445
Catalog Number3445
Company DUNS117844489
Company NameBionix, LLC
Device Count50
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100714646001344 [Primary]
GS110714646001341 [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 Date2025-03-05
Device Publish Date2025-02-25

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.