FDA.reportPublic FDA data

Bar Phantom

Primary DI
00718175009352
Brand
Bar Phantom
Company
BIODEX MEDICAL SYSTEMS, INC.
Model
243-935
Catalog number
243-935
Device description
Bar Phantom, Rectangular
Published
2018-02-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JARPhantom, Test-Pattern, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JARPhantom, Test-Pattern, RadionuclideRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00718175009352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175009352007181750093527181750093520718175009352

GMDN Terms#

Term, Definition table
TermDefinition
Nuclear medicine phantom, test objectA device that includes a wide variety of two or three-dimensional (3-D) phantoms used in both calibration protocols and in subjective and quantitative evaluations of the performance of diagnostic nuclear medicine (NM) detector systems, e.g., gamma cameras, single photon emission computed tomography (SPECT), positron emission tomography (PET) or associated image display system and software programs. It consists of either fixed or variable configurations or patterns of absorbing or attenuating materials and radioactive source holders. The design can incorporate radioactive sealed sources or refillable radioactive source wells to which radioactivity can be added.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043833813
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00718175003381SHARPS CONTAINER SHIELD 039-350039-3502019-05-31
00718175003657Neck Phantom 043-365043-3652018-02-15
00718175005002Xenon Rebreathing System 132-680132-6802019-09-30
00718175005019Xenon Rebreathing System 132-681132-6812019-10-16
00718175005040Xenon Rebreathing System 132-690132-6902019-10-16
00718175005057Xenon Rebreathing System 132-691132-6912019-10-16
00718175005064Xenon Rebreathing System 132-692132-6922019-10-16
00718175005071Xenon Rebreathing System 132-699132-6992019-10-16
00718175005088Xenon Rebreathing System 132-770132-7702019-10-16
00718175005101Xenon Rebreathing System 132-774132-7742019-10-17
00718175005125Xenon Rebreathing System 132-784132-7842019-10-16
00718175005132Xenon Rebreathing System 132-793132-7932019-10-16
00718175005149Xenon Rebreathing System 132-771132-7712019-10-16
00718175005156VENTI-SCAN IV177-075177-0752019-12-13
00718175005163AIR CUSHIONED FACE MASK132-685132-6852019-12-13
00718175005170AIR CUSHIONED FACE MASK132-695132-6952019-12-13
00718175005187AIR CUSHIONED FACE MASK132-698132-6982019-12-13
00718175005200BACTERIAL FILTER132-750132-7502019-12-13
00718175005248XENON CONVENIENCE KITS 134-772134-7722019-12-13
00718175002902LEAD LINED 244-157244-1572020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060608882038Capintec NEMA IEC NM Body PhantomSUN NUCLEAR CORP.JAR2025-11-07
00810117210311Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.JAR2022-12-07
00810117210328Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.JAR2022-12-07
00810117210335Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.JAR2022-12-07
00810117210342Eckert & Ziegler Isotope Products, Inc.Eckert & Ziegler Isotope Products, Inc.JAR2022-12-07
00718175003800Bar PhantomBIODEX MEDICAL SYSTEMS, INC.JAR2018-02-15
00718175003985Bar PhantomBIODEX MEDICAL SYSTEMS, INC.JAR2018-02-15
00718175004395Bar PhantomBIODEX MEDICAL SYSTEMS, INC.JAR2018-02-15
00718175008164Bar PhantomBIODEX MEDICAL SYSTEMS, INC.JAR2018-02-15
00718175009550Bar PhantomBIODEX MEDICAL SYSTEMS, INC.JAR2018-02-15
00718175009871Bar PhantomBIODEX MEDICAL SYSTEMS, INC.JAR2018-02-15