ClearLook Lighted MicroLoop, Refill 3420

GUDID 10714646001310

ClearLook Lighted MicroLoop, 50ct Refill

Bionix, LLC

ENT illuminating foreign body extraction set
Primary Device ID10714646001310
NIH Device Record Keyfa07cde6-0d06-4c49-8cd1-ce27f594dc4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearLook Lighted MicroLoop, Refill
Version Model Number3420
Catalog Number3420
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
GS100714646001313 [Primary]
GS110714646001310 [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

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00714646001436 - Prone Breast, Hardware Kit, Threaded Indexing Pegs2025-06-05 Prone Breast, Hardware Kit, Threaded Indexing Pegs
00714646001443 - Prone Breast, Hardware Kit, Head Rest Push Button Assembly Replacement2025-06-05 Prone Breast, Hardware Kit, Head Rest Push Button Assembly, Replacement
00714646001450 - Prone Breast, Hardware Kit, Head Rest Carriage, Replacement2025-06-05 Prone Breast, Hardware Kit, Head Rest Carriage, Replacement

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