CIVCO MEDICAL INSTRUMENTS CO., INC.

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

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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

System, imaging, pulsed echo, ultrasonic (IYO) (5) Transducer, ultrasonic, diagnostic (ITX) (5)

Premarket Exempt

No Yes

Clear

eTRAX™ Needle System Starter Kit - 00841436100519 Catalog Number : 10854388

Device Description : Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7. Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.8 tapered to 3.8 x 147cm) CIV-Flex™ covers for use with 3D Guidance driveBAY™, driveBAY™ 2, trakSTAR™, or trakSTAR™ 2 trackers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

eTRAX™ Needle System Starter Kit - 00841436100526 Catalog Number : 10855226

Device Description : Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers for use with 3D Guidance driveBAY™ , driveBAY™ 2, trakSTAR™ or trakSTAR™ 2 trackers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

eTRAX™ Needle System Starter Kit - 00841436100533 Catalog Number : 10855227

Device Description : Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5) and (7 Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5) and (7.6 tapered to 3.8 x 147 cm) CIV-Flex™ covers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100540 Catalog Number : 11001906

Device Description : Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guide Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infiniti Plus™ (18, 20, 21/22, 25GA) needle guides (3), (14 x 29.2cm) CIV-Flex™ wireless transducer covers (5) for use with Siemens L8-3 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100557 Catalog Number : 11001907

Device Description : Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x Reusable non-sterile single-angle bracket with AccuSITE needle guides (5), (14 x 29.2cm) CIV-Flex™ wireless transducer covers (5) for use with Siemens L13-5 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Needle Guide - 00841436100663 Catalog Number : 04392143

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 6.5EV13, 6.5EV13+, 6.5EV13S AND EV9-4 (on SONOLINE G20, G50, G60 S systems) transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100670 Catalog Number : 04838723

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), and cleaning brushes (5) for use with Siemens C5-2 and CX5-2 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100687 Catalog Number : 04838749

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 9L4, VF10-5, VF7-3, and VFX9-4 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100694 Catalog Number : 04838756

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 14L5, VF13-5 and VFX13-5 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100816 Catalog Number : 5304800-2

Device Description : Reusable non-sterile position sensor mount multi-angle brackets (4) with Ultra-P Reusable non-sterile position sensor mount multi-angle brackets (4) with Ultra-Pro II™ Needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5) for use with GE Healthcare 9L, C1-5, ML6-15 and S1-5 Volume Navigation transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 4

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