FDA.reportPublic FDA data

Capintec Dose Calibrator

Primary DI
00859942006065
Brand
Capintec Dose Calibrator
Company
Mirion Technologies (capintec), Inc.
Model
CRC-77tHR
Catalog number
5130-30261
Device description
Radioisotope Dose Calibrator
Published
2017-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KPTCalibrator, Dose, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPTCalibrator, Dose, RadionuclideRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162394000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162394000CRC-77tHRCapintec, Inc.2017-03-08KPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859942006065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859942006065008599420060658599420060650859942006065

GMDN Terms#

Term, Definition table
TermDefinition
Radioisotope calibration systemA system of radioactivity measuring instruments designed for quantifying the amount of radiation in a radiopharmaceutical dose or other test samples inserted into a shielded chamber or well for measurement. The system's instruments radiation level measurements in units of Curie and/or Becquerel are used to quantify the radioactivity in diagnostic or therapeutic radiopharmaceuticals prior to and after patient administration. This will be used to measure radiation levels of in vitro diagnostic test samples, e.g., those required for Schilling tests, Cr-51 or I-125 blood volume.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
047684501
Device count
1
Serial number
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
00718175003343Atomlab Wipe Test CounterBIODEX MEDICAL SYSTEMS, INC.KPT2020-02-14
08719324589017VIK203Comecer Netherlands B.V.KPT2018-02-06
08719324589024IBC-LiteComecer Netherlands B.V.KPT2018-02-06
08719324589048VDC606Comecer Netherlands B.V.KPT2018-02-06
08719324589000VIK202Comecer Netherlands B.V.KPT2018-02-05
00718175003305Atomlab 500 Dose CalibratorBIODEX MEDICAL SYSTEMS, INC.KPT2016-11-02
00718175003329Atomlab 500 PlusBIODEX MEDICAL SYSTEMS, INC.KPT2016-11-02
00718175003350Atomlab Dose CalibratorBIODEX MEDICAL SYSTEMS, INC.KPT2016-11-02
00866562000212Standard Imaging HDR 1000 PlusSTANDARD IMAGING INC.KPT2016-10-11
00866562000250Standard Imaging IVB 1000 Well ChamberSTANDARD IMAGING INC.KPT2016-10-11
00859942006072Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-27
00859942006089Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-27
00859942006003Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006010Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006027Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006034Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006041Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006058Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00813787020280I-Seed Agx100THERAGENICS CORPORATIONKPT2015-09-21
00813787020297I-Seed Agx100THERAGENICS CORPORATIONKPT2015-09-21
00813787020754TheraSeedTHERAGENICS CORPORATIONKPT2015-09-21
00813787020761TheraSeedTHERAGENICS CORPORATIONKPT2015-09-21