Bar Phantom 243-986

GUDID 00718175004395

Bar Phantom, Symbia and E-Cam

BIODEX MEDICAL SYSTEMS, INC.

Nuclear medicine phantom, test object Nuclear medicine phantom, test object
Primary Device ID00718175004395
NIH Device Record Key7d3a695d-a32a-41c8-9c9d-51dada072c67
Commercial Distribution StatusIn Commercial Distribution
Brand NameBar Phantom
Version Model Number243-986
Catalog Number243-986
Company DUNS043833813
Company NameBIODEX MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100718175004395 [Primary]

FDA Product Code

JARPhantom, Test-Pattern, Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2018-02-15

On-Brand Devices [Bar Phantom]

00718175009871Bar Phantom, Symbia, 21" X 16"
00718175009550Bar Phantom, Cardiac, High Resolution
00718175009352Bar Phantom, Rectangular
00718175008164Bar Phantom, GE
00718175004395Bar Phantom, Symbia and E-Cam
00718175003985Bar Phantom, E CAM, 4-Quadrant
00718175003800Bar Phantom, Standard, High Resolution

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.