CIVCO MEDICAL INSTRUMENTS CO., INC.

Address:102 FIRST ST. SOUTH,Kalona,IA,52247,US

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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

Transducer, ultrasonic, diagnostic (ITX) (7) System, imaging, pulsed echo, ultrasonic (IYO) (2) EVACUATOR, GASTRO-UROLOGY (KQT) (1)

Premarket Exempt

No Yes

Clear

Cook CollectEVAC - 00827002515499 Catalog Number : G51549

Device Description : Cook CollectEVAC

Device Class : 2

Duns Number: 134614411

Premarket Exempt : Yes

Product Code : KQT

Prescription Use : Yes

Device Count : 1

Biopsy Bracket - 00841436100014 Catalog Number : 07471134

Device Description : Reusable non-sterile multi-angle bracket with cleaning brushes (5) for use with Reusable non-sterile multi-angle bracket with cleaning brushes (5) for use with Siemens 4V1 and PH4-I transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Biopsy Bracket - 00841436100021 Catalog Number : 07471159

Device Description : Reusable non-sterile single-angle bracket with cleaning brushes (5) for use with Reusable non-sterile single-angle bracket with cleaning brushes (5) for use with Siemens CH6-2 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100038 Catalog Number : 07472314

Device Description : Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), ( Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (17.8 x 91.5cm) CIV-Flex™ covers (5) and cleaning brushes (5) for use with Siemens CH4-1 and CH5-2 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100045 Catalog Number : 07472322

Device Description : Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) and cleaning brushes (5) for use with Siemens CH6-2 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100052 Catalog Number : 07472330

Device Description : Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), ( Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5), and cleaning brushes (5) for use with Siemens 4V1 and PH4-1 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100069 Catalog Number : 07843159

Device Description : Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), ( Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5), (17.8 x 91.5cm) CIV-Flex™ covers (5), and cleaning brushes (5) for use with Siemens 7CF2, C7F2 and C5F1 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Needle Guide - 00841436100076 Catalog Number : 07848141

Device Description : Reusable non-sterile needle guide with cleaning brushes (5) for use with Philips Reusable non-sterile needle guide with cleaning brushes (5) for use with Philips C10-4ec transducers Siemens 6.5EC10, EC7, EC9-4 (SONOLINE G20, G50, G60S, ACUSON X500) and EC10C5 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Needle Guide - 00841436100083 Catalog Number : 08245962

Device Description : Reusable non-sterile needle guide with cleaning brushes (5) for use with Siemens Reusable non-sterile needle guide with cleaning brushes (5) for use with Siemens EV-8C4 and EVC8 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100090 Catalog Number : 08256947

Device Description : Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), Reusable non-sterile single-angle bracket with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 5C2g, 6C2 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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