Prone Breast Bridge: Large PBRT-6240

GUDID 00714646000446

Prone Breast Bridge: Large

Bionix, LLC

Radiological whole-body positioner
Primary Device ID00714646000446
NIH Device Record Key29e3243f-5215-4735-96bd-eadab9f1c44e
Commercial Distribution StatusIn Commercial Distribution
Brand NameProne Breast Bridge: Large
Version Model NumberPBRT-6240
Catalog NumberPBRT-6240
Company DUNS117844489
Company NameBionix, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
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
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
GS100714646000446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-17
Device Publish Date2022-08-09

Devices Manufactured by Bionix, LLC

00714646001382 - Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, Replacement2025-06-05 Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, Replacement
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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