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

Holder, Syringe, Lead (IWR) (8) Phantom, Anthropomorphic, Nuclear (IYP) (1) Probe, Uptake, Nuclear (IZD) (1)

Premarket Exempt

No Yes

Clear

Capintec Neck Phantom - 00859942006324 Catalog Number : 5230-0038

Device Description : Thyroid Uptake Neck Phantom

Device Class : 1

Duns Number: 047684501

Premarket Exempt : Yes

Product Code : IYP

Prescription Use : No

Device Count : 1

Captus 4000e Thyroid Uptake System with 2 in well - 00859942006423 Catalog Number : 5430-30154

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. This model includes a well counter with 2 inch of lead shielding.

Device Class : 1

Duns Number: 047684501

Premarket Exempt : Yes

Product Code : IZD

Prescription Use : Yes

Device Count : 1

Pro-Tec II 3 cc with lead glass window - 00859942006492 Catalog Number : 007-800

Device Description : Tungsten syringe shield

Device Class : 1

Duns Number: 047684501

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : No

Device Count : 1

Pro-Tec II 3 cc without glass window - 00859942006508 Catalog Number : 007-801

Device Description : Tungsten Syringe Shield without window

Device Class : 1

Duns Number: 047684501

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : No

Device Count : 1

Pro-Tec II 5 cc with lead glass window - 00859942006515 Catalog Number : 007-900

Device Description : Tungsten Syringe Shield with lead glass window

Device Class : 1

Duns Number: 047684501

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : No

Device Count : 1

Pro-Tec II 5 cc - 00859942006522 Catalog Number : 007-901

Device Description : Tungsten Syringe Shield

Device Class : 1

Duns Number: 047684501

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : No

Device Count : 1

Pro-Tec III 1 cc, BD Luer Lok - 00859942006539 Catalog Number : 007-723

Device Description : Tungsten Syringe Shield

Device Class : 1

Duns Number: 047684501

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : No

Device Count : 1

Pro-Tec III 1 cc - 00859942006546 Catalog Number : 007-734

Device Description : Tungsten Syringe Shield

Device Class : 1

Duns Number: 047684501

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : No

Device Count : 1

Pro-Tec III 3 cc - 00859942006553 Catalog Number : 007-735

Device Description : Tungsten Syringe Shield

Device Class : 1

Duns Number: 047684501

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : No

Device Count : 1

Pro-Tec III 5 cc - 00859942006560 Catalog Number : 007-736

Device Description : Tungsten Syringe Shield

Device Class : 1

Duns Number: 047684501

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : No

Device Count : 1

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