Sample, Lighted Placement Tool 22850

GUDID 00714646001030

Sample, Lighted Placement Tool

Bionix, LLC

Earmould impression block insertion tool
Primary Device ID00714646001030
NIH Device Record Key600430a2-bdf0-431f-bc83-2f654f24ab24
Commercial Distribution StatusIn Commercial Distribution
Brand NameSample, Lighted Placement Tool
Version Model NumberSP-22850
Catalog Number22850
Company DUNS117844489
Company NameBionix, LLC
Device Count1
DM Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100714646001030 [Primary]

FDA Product Code

JYGCURETTE, EAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-06-19
Device Publish Date2022-10-27

Devices Manufactured by Bionix, LLC

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00714646001399 - Prone Breast, Face Cushion, Replacement2025-06-05 Prone Breast, Face Cushion, Replacement
00714646001405 - Prone Breast, Arm Rest, Replacement2025-06-05 Prone Breast, Arm Rest, Replacement
00714646001412 - Prone Breast, Leg Cushion, Replacement2025-06-05 Prone Breast, Leg Cushion, Replacement
00714646001429 - Prone Breast, Hand Post Assembly, Replacement2025-06-05 Prone Breast, Hand Post Assembly, Replacement
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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