CLINICAL INNOVATIONS, LLC

Address:747 W 4170 S,MURRAY,UT,84123,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

Extractor, Vacuum, Fetal (HDB) (5) Cannula, Manipulator/Injector, Uterine (LKF) (2) Electrode, Circular (Spiral), Scalp And Applicator (HGP) (2) Tube, Aspirating, Flexible, Connecting (BYY) (1)

Premarket Exempt

No Yes

Clear

FSE Cables - 00814247020581 Catalog Number :

Device Description : Cables to FSE

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HGP

Prescription Use : Yes

Device Count : 1

FSE Cables - 00814247020598 Catalog Number :

Device Description : Cables to FSE

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HGP

Prescription Use : Yes

Device Count : 1

ClearView Uterine Manipulator - 00814247020604 Catalog Number :

Device Description : ClearView Uterine Manipulator, 9cm

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

ClearView Total Uterine Manipulator - 00814247020611 Catalog Number :

Device Description : ClearView Total Uterine Manipulator, 9cm tip

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

Kiwi® Omni-C Cup® - 00814247020628 Catalog Number :

Device Description : Kiwi® Vacuum Delivery System, Omni-C Cup® for Cesarean Section

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HDB

Prescription Use : Yes

Device Count : 1

Kiwi® OmniCup® - 00814247020635 Catalog Number :

Device Description : Kiwi® Vacuum Delivery System, OmniCup®

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HDB

Prescription Use : Yes

Device Count : 1

Kiwi® OmniCup® - 00814247020642 Catalog Number :

Device Description : Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HDB

Prescription Use : Yes

Device Count : 1

Kiwi® OmniCup® - 00814247020659 Catalog Number :

Device Description : Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HDB

Prescription Use : Yes

Device Count : 1

Kiwi® ProCup® - 00814247020666 Catalog Number :

Device Description : Kiwi® Vacuum Delivery System ProCup®

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HDB

Prescription Use : Yes

Device Count : 1

BoogieBaby nasal aspirator – preemie tip - 00814247020680 Catalog Number :

Device Description : BoogieBaby nasal aspirator – preemie tip

Device Class :

Duns Number: 809524291

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : Yes

Device Count : 1

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