Prone Breast, Arm Rest, Replacement PBRT-6255

GUDID 00714646001405

Prone Breast, Arm Rest, Replacement

Bionix, LLC

Radiological whole-body positioner
Primary Device ID00714646001405
NIH Device Record Key985abc77-089e-46cc-a254-70726633fc48
Commercial Distribution StatusIn Commercial Distribution
Brand NameProne Breast, Arm Rest, Replacement
Version Model NumberPBRT-6255
Catalog NumberPBRT-6255
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 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
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100714646001405 [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 Date2025-06-05
Device Publish Date2025-05-28

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, Replacement2025-06-05Prone Breast, Arm Rest, 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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.