FDA.reportPublic FDA data

Neck Phantom

Primary DI
00718175003657
Brand
Neck Phantom
Company
BIODEX MEDICAL SYSTEMS, INC.
Model
043-365
Catalog number
043-365
Device description
Neck Phantom, Thyroid Uptake
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
IYPPhantom, Anthropomorphic, Nuclear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYPPhantom, Anthropomorphic, NuclearRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00718175003657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175003657007181750036577181750036570718175003657

GMDN Terms#

Term, Definition table
TermDefinition
Nuclear medicine phantom, anthropomorphicA device that consists of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to mimic the functional, physical, or a combination of these characteristics of normal or diseased human organs. It is used in diagnostic nuclear medicine and incorporates radioactive sealed sources or refillable cavities to which radioactivity can be added in order to simulate anticipated in vivo distributions of radiopharmaceuticals used in nuclear medicine imaging procedures. It is a quality assurance (QA) device permitting both subjective and quantitative evaluation of the overall function of photon detector systems, e.g., gamma camera, SPECT or PET.

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
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
00718175087640BETA, Syringe Shield 007-958007-9582021-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850020486004Clearsight BolusCLEARSIGHT RT LLCIYP2022-05-13
00850020486007Clearsight BolusCLEARSIGHT RT LLCIYP2022-05-13
10850020486011Clearsight BolusCLEARSIGHT RT LLCIYP2022-05-13
10850020486028Clearsight BolusCLEARSIGHT RT LLCIYP2022-05-13
10850020486035Clearsight BolusCLEARSIGHT RT LLCIYP2022-05-13
10850020486042Clearsight BolusCLEARSIGHT RT LLCIYP2022-05-13
10850020486059Clearsight BolusCLEARSIGHT RT LLCIYP2022-05-13
00859942006324Capintec Neck PhantomMirion Technologies (capintec), Inc.IYP2019-07-01