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) (9) System, imaging, pulsed echo, ultrasonic (IYO) (1)

Premarket Exempt

No Yes

Clear

Transducer Cover - 10841436118641 Catalog Number : 610-2328, 610-2328-5

Device Description : Sterile (14 x 244cm) telescopically-folded CIV-Flex cover with PEELSafe Advantage

Device Class : 2

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Integrated Needle Guide - 10841436118702 Catalog Number : 680-172, 680-172-5

Device Description : Sterile needle guide with (17.8 x 147cm) telescopically-folded CIV-Flex™ cover f Sterile needle guide with (17.8 x 147cm) telescopically-folded CIV-Flex™ cover for use with Canon Medical Systems PVI-450BPX (i8CXP1) transducers

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Verza Guidance System - 10841436118740 Catalog Number : 610-1501-5, 610-1501-24, 610-1501-MC

Device Description : Ultrasound guide for use with VerzaLink™ enabled transducers and brackets with ( Ultrasound guide for use with VerzaLink™ enabled transducers and brackets with (14 × 147cm) telescopically folded CIV-Flex™ cover

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

CIV-Flex™ Transducer Cover - 10841436119907 Catalog Number : 610-542TR

Device Description : 14 x 91.5cm telescopically-folded cover

Device Class : 2

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

AccuSITE™ Needle Guide - 10841436120002 Catalog Number : 610-2337

Device Description : Sterile needle guide with (14x147cm) CIV-flex cover with Enviision saline wipe

Device Class : 2

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

AccuSITE™ Needle Guide - 10841436120019 Catalog Number : 610-2338

Device Description : Sterile needle guide (20ga) with (14x147cm) CIV-flex cover with Enviision saline wipe

Device Class : 2

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

AccuSITE™ Needle Guide - 10841436120026 Catalog Number : 610-2339

Device Description : Sterile needle guide (21ga) with (14x147cm) CIV-flex cover with Enviision saline wipe

Device Class : 2

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Infiniti Plus Needle Guide - 10841436120033 Catalog Number : 610-2340

Device Description : Sterile needle guide (18ga) with (14x147cm) CIV-flex cover with Enviision saline wipe

Device Class : 2

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Infiniti Plus Needle Guide - 10841436120040 Catalog Number : 610-2341

Device Description : Sterile needle guide (12-18ga) with (14x147cm) CIV-flex cover with Enviision saline wipe

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

BX2 Needle Guide - 10841436120057 Catalog Number : 644-094, 644-094-5

Device Description : Sterile needle guide with (14x91.5cm) CIV-Flex cover for use with Hitachi C23 an Sterile needle guide with (14x91.5cm) CIV-Flex cover for use with Hitachi C23 and C23RV transducer

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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