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) (10)

Premarket Exempt

No Yes

Clear

AccuSITE™ Needle Guide - 10841436120101 Catalog Number : 610-2342

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

Device Class : 2

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

AccuSITE™ Needle Guide - 10841436120118 Catalog Number : 610-2343

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

Device Class : 2

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

AccuSITE™ Needle Guide - 10841436120125 Catalog Number : 610-2344

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

Device Class : 2

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Infiniti Plus Needle Guide - 10841436120132 Catalog Number : 610-2345

Device Description : Sterile needle guide (18-25ga) with (14 x 147cm) telescopically-folded CIV-Flex™ Sterile needle guide (18-25ga) with (14 x 147cm) telescopically-folded CIV-Flex™ cover with Envision™

Device Class : 2

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

Infiniti Plus Needle Guide - 10841436120149 Catalog Number : 610-2346

Device Description : Sterile needle guide (12-18ga) with (14 x 147cm) telescopically-folded CIV-Flex™ Sterile needle guide (12-18ga) with (14 x 147cm) telescopically-folded CIV-Flex™ cover with Envision™

Device Class : 2

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

CIV-Clear™ Transducer Cover - 10841436120262 Catalog Number : 610-2361, 610-2361-5

Device Description : Sterile (14x61cm) flat-folded cover

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

CIV-Clear™ Transducer Cover - 10841436120279 Catalog Number : 610-2362, 610-2362-5

Device Description : Sterile (14x91.5cm) telescopically-folded cover

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

CIV-Clear™ Transducer Cover - 10841436120286 Catalog Number : 610-2363, 610-2363-5

Device Description : Sterile (14x122cm) telescopically-folded cover

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

CIV-Clear™ Transducer Cover - 10841436120293 Catalog Number : 610-2364, 610-2364-5

Device Description : Sterile (8.9x91.5cm) telescopically-folded cover

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

CIV-Clear™ Transducer Cover - 10841436120309 Catalog Number : 610-2365, 610-2365-5

Device Description : Sterile (10.2x122cm) telescopically-folded cover

Device Class :

Duns Number: 134614411

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

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