Pelvis Belly Replacement Face Cushion Assembly PPRT-5107

GUDID 00714646001504

Pelvis Belly Replacement Face Cushion Assembly

Bionix, LLC

Radiological whole-body positioner
Primary Device ID00714646001504
NIH Device Record Key9960ebb7-56c6-4610-a2c0-cbd8271668d9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePelvis Belly Replacement Face Cushion Assembly
Version Model NumberPPRT-5107
Catalog NumberPPRT-5107
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100714646001504 [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 Date2025-08-29
Device Publish Date2025-08-21

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 Assembly2025-08-29Pelvis Belly Replacement Face Cushion Assembly
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.