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

System, imaging, pulsed echo, ultrasonic (IYO) (8) Transducer, ultrasonic, diagnostic (ITX) (2)

Premarket Exempt

No Yes

Clear

Biopsy Bracket - 00841436100243 Catalog Number : 10044759

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 18L6 HD transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Biopsy Starter Kit - 00841436100250 Catalog Number : 10136145

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 8C3 HD transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Tracking Bracket Starter Kit - 00841436100274 Catalog Number : 10441183

Device Description : Reusable non-sterile multi-angle tracking bracket with Ultra-Pro II™ Needle guid Reusable non-sterile multi-angle tracking bracket with Ultra-Pro II™ Needle guides (5), (17.8 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 4C1 and 6C1 HD transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Tracking Bracket Starter Kit - 00841436100281 Catalog Number : 10441184

Device Description : Reusable non-sterile tracking bracket with (17.8 x 147cm) CIV-Flex™ covers (5), Reusable non-sterile tracking bracket with (17.8 x 147cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 4C1 and 6C1 HD transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Tracking Bracket Starter Kit - 00841436100298 Catalog Number : 10441187

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

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Tracking Bracket Starter Kit - 00841436100304 Catalog Number : 10441188

Device Description : Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5), c Reusable non-sterile tracking bracket with (14 x 91.5cm) CIV-Flex™ covers (5), cleaning brushes (5) for use with Siemens 4V1 transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Biopsy Bracket Starter Kit - 00841436100311 Catalog Number : 10441189

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

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Tracking Bracket Starter Kit - 00841436100328 Catalog Number : 10441190

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

General Purpose Sensor - 00841436100335 Catalog Number : 10441627

Device Description : Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guid Non-sterile reusable general purpose electromagnetic sensor 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 - 00841436100342 Catalog Number : 10441628

Device Description : Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7. Reusable non-sterile needle sensor with sterile (16GA 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 : 2

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

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