FDA.reportPublic FDA data

Capintec Neck Phantom

Primary DI
00859942006324
Brand
Capintec Neck Phantom
Company
Mirion Technologies (capintec), Inc.
Model
5230-0038
Catalog number
5230-0038
Device description
Thyroid Uptake Neck Phantom
Published
2019-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00859942006324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859942006324008599420063248599420063240859942006324

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

Contacts#

Phone, Email table
PhoneEmail
201-825-9500getinfo@capintec.com

Regulatory Flags#

DUNS number
047684501
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859942006287CII Transporter0670-00070670-00072019-07-01
00859942006294CII Transporter II0670-20260670-20262019-07-01
008599420063002 cc Pin-Tec Syringe Shield4300-00604300-00602019-07-01
00859942006126Capintec Syringe Shield1 cc Pin-Tec Syringe Shield4300-00342018-11-28
00859942006133Capintec Syringe Shield3 cc PIn-Tec Syringe Shield4300-00352018-11-28
00859942006140Capintec Syringe Shield5 cc Pin-Tec Syringe Shield4300-00362018-11-28
00859942006157Capintec Syringe Shield10 cc Pin-Tec Syringe Shield4300-00372018-11-28
00859942006164Capintec Syringe Shield1 cc C-Tec Syringe Shield4300-00302018-11-28
00859942006171Capintec Syringe Shield3 cc C-Tec Syringe Shield4300-00312018-11-28
00859942006188Capintec Syringe Shield5 cc C-Tec Syringe Shield4300-00322018-11-28
00859942006195Capintec Syringe Shield10 cc C-Tec Syringe Shield4300-00332018-11-28
00859942006201Capintec Syringe Shield511 C-Tec Syringe Shield, 5 cc0665-20202018-11-28
00859942006218Capintec Syringe Shield511 C-Tec Syringe Shield, 10 cc0665-20152018-11-28
00859942006225Capintec Syringe Shield511 C-Tec Syringe Shield, 20 cc0665-20212018-11-28
00859942006263Capintec T-Vial ShieldT-Vial Shield0665-00022018-11-28
00879942070750MRI Stretcher240-100240-1002023-07-31
00879942070767MRI Stretcher with Fowler Positioning240-110240-1102023-07-31
00879942070644Ultra Pro Ultrasound Table, 230V058-725058-7252023-07-21
00879942070613Sound Pro Combination Ultrasound Table, 115V058-710058-7102023-07-14
00879942070620Sound Pro Combination Ultrasound Table, 230V058-715058-7152023-07-14

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
00718175003657Neck Phantom BIODEX MEDICAL SYSTEMS, INC.IYP2018-02-15