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) (3)

Premarket Exempt

No Yes

Clear

Biopsy Starter Kit - 00841436100106 Catalog Number : 08256950

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™ cover(5), cleaning brushes (5) for use with Siemens 4V1 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100113 Catalog Number : 08260150

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), cleaning brushes (5) for use with Siemens 4C1 and 6C1HD transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Biopsy Bracket - 00841436100120 Catalog Number : 08260151

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 4C1 and 6C1HD transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Needle Guide - 00841436100144 Catalog Number : 08651387

Device Description : Reusable non-sterile endocavity needle guide (short) with cleaning brushes (5) f Reusable non-sterile endocavity needle guide (short) with cleaning brushes (5) for use with Siemens BE9-4 transducer

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Transducer Cover - 00841436100151 Catalog Number : 08990418

Device Description : Non-sterile (3.2 tapered to 1.9 x 32cm) latex cover

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 100

Needle Guide - 00841436100175 Catalog Number : 10031556

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 9EVF4 and EV9F4 (S2000) transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100182 Catalog Number : 10037928

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 17L5 HD transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Biopsy Bracket - 00841436100199 Catalog Number : 10038223

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Needle Guide - 00841436100229 Catalog Number : 10041823

Device Description : Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use w Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with Siemens EC9-4 and EV9-4 (SONOLINE G40 and ACUSON X150, X300 systems) transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100236 Catalog Number : 10044200

Device Description : Reusable non-sterile multi-angle bracket with Ultra-Pro II™ Needle guides (5) (1 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 18L6 HD transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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