CLINICAL INNOVATIONS, LLC

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

Clamp, Circumcision (HFX) (4) Cannula, Manipulator/Injector, Uterine (LKF) (3) Extractor, Vacuum, Fetal (HDB) (1) Instrument, Manual, General Obstetric-Gynecologic (KOH) (1) Transducer, Pressure, Intrauterine (HFN) (1)

Premarket Exempt

No Yes

Clear

Kiwi® OmniCup® - 00814247020000 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

ClearView Uterine Manipulator - 00814247020017 Catalog Number :

Device Description : ClearView Uterine Manipulator, 7cm

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

AccuCirc® - 00814247020031 Catalog Number :

Device Description : AccuCirc® Circumcision Device

Device Class :

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFX

Prescription Use : Yes

Device Count : 1

AccuCirc® - 00814247020055 Catalog Number :

Device Description : AccuCirc® Circumcision Device

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFX

Prescription Use : Yes

Device Count : 1

AccuCirc® - 00814247020079 Catalog Number :

Device Description : AccuCirc® Circumcision Device

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFX

Prescription Use : Yes

Device Count : 1

AccuCirc® - 00814247020093 Catalog Number :

Device Description : AccuCirc® Circumcision Device

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFX

Prescription Use : Yes

Device Count : 1

C-Snorkel - 00814247020116 Catalog Number :

Device Description : C-Snorkel Caesarean Section Vacuum Release Device

Device Class :

Duns Number: 809524291

Premarket Exempt : Yes

Product Code : KOH

Prescription Use : Yes

Device Count : 1

ClearView - 00814247020130 Catalog Number :

Device Description : Sound/Dilator (accessory for ClearView Uterine Manipulator)

Device Class :

Duns Number: 809524291

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

ClearView - 00814247020147 Catalog Number :

Device Description : ClearView accessory - Disposable Sound Dilator

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

Koala® - 00814247020154 Catalog Number :

Device Description : Koala® Intrauterine Pressure Catheter with internal balloon

Device Class :

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFN

Prescription Use : Yes

Device Count : 1

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