CAPINTEC, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Calibrator, Dose, Radionuclide (KPT) (9) Probe, Uptake, Nuclear (IZD) (1)

Premarket Exempt

No Yes

Clear

Capintec Dose Calibrator - 00859942006003 Catalog Number :

Device Description : Radioisotope Dose Calibrator

Device Class : 2

Duns Number: 047684501

Premarket Exempt : No

Product Code : KPT

Prescription Use : Yes

Device Count : 1

Capintec Dose Calibrator - 00859942006010 Catalog Number :

Device Description : Radioisotope Dose Calibrator

Device Class : 2

Duns Number: 047684501

Premarket Exempt : No

Product Code : KPT

Prescription Use : Yes

Device Count : 1

Capintec Dose Calibrator - 00859942006027 Catalog Number :

Device Description : Radioisotope Dose Calibrator

Device Class : 2

Duns Number: 047684501

Premarket Exempt : No

Product Code : KPT

Prescription Use : Yes

Device Count : 1

Capintec Dose Calibrator - 00859942006034 Catalog Number :

Device Description : Radioisotope Dose Calibrator

Device Class : 2

Duns Number: 047684501

Premarket Exempt : No

Product Code : KPT

Prescription Use : Yes

Device Count : 1

Capintec Dose Calibrator - 00859942006041 Catalog Number :

Device Description : Radioisotope Dose Calibrator

Device Class : 2

Duns Number: 047684501

Premarket Exempt : No

Product Code : KPT

Prescription Use : Yes

Device Count : 1

Capintec Dose Calibrator - 00859942006058 Catalog Number :

Device Description : Radioisotope Dose Calibrator

Device Class : 2

Duns Number: 047684501

Premarket Exempt : No

Product Code : KPT

Prescription Use : Yes

Device Count : 1

Capintec Dose Calibrator - 00859942006065 Catalog Number : 5130-30261

Device Description : Radioisotope Dose Calibrator

Device Class : 2

Duns Number: 047684501

Premarket Exempt : No

Product Code : KPT

Prescription Use : Yes

Device Count : 1

Capintec Dose Calibrator - 00859942006072 Catalog Number : 5130-20253

Device Description : Radioisotope Dose Calibrator

Device Class : 2

Duns Number: 047684501

Premarket Exempt : No

Product Code : KPT

Prescription Use : Yes

Device Count : 1

Capintec Dose Calibrator - 00859942006089 Catalog Number : 5130-20254

Device Description : Radioisotope Dose Calibrator

Device Class : 2

Duns Number: 047684501

Premarket Exempt : No

Product Code : KPT

Prescription Use : Yes

Device Count : 1

Captus 4000e Thyroid Uptake System - 00859942006096 Catalog Number : 5430-30151

Device Description : The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designe The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module.

Device Class : 1

Duns Number: 047684501

Premarket Exempt : Yes

Product Code : IZD

Prescription Use : No

Device Count : 1

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