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

Immunoassay For Detection Of Amniotic Fluid Protein(S). (NQM) (4) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Support, Patient Position (CCX) (2) Cannula, Manipulator/Injector, Uterine (LKF) (1) Monitor, Uterine Contraction, External (For Use In Clinic) (HFM) (1)

Premarket Exempt

No Yes

Clear

Koala Toco® - 00814247020284 Catalog Number :

Device Description : Koala Toco® Single-Use Tocodyamometer

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFM

Prescription Use : Yes

Device Count : 1

traxi® Panniculus Retractor - 00814247020345 Catalog Number :

Device Description : Traxi Panniculus Retractor with Retentus Technology (BMI 30-50)

Device Class : 1

Duns Number: 809524291

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : Yes

Device Count : 1

traxi® Panniculus Retractor Extender - 00814247020369 Catalog Number :

Device Description : Traxi Extender (BMI>50 - used with PH-25)

Device Class : 1

Duns Number: 809524291

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : Yes

Device Count : 1

ROM Plus®, Fetal Membranes Rupture Test - 00814247020406 Catalog Number :

Device Description : ROM Plus® Easy Strip Complete Kit Fetal Membranes Rupture Test

Device Class :

Duns Number: 809524291

Premarket Exempt : No

Product Code : NQM

Prescription Use : Yes

Device Count : 1

ROM Plus®, Fetal Membranes Rupture Test - 00814247020420 Catalog Number :

Device Description : ROM Plus® Complete Test Kit

Device Class : 1

Duns Number: 809524291

Premarket Exempt : No

Product Code : NQM

Prescription Use : Yes

Device Count : 1

ROM Plus®, Fetal Membranes Rupture Test - 00814247020437 Catalog Number :

Device Description : ROM Plus® Complete Kit Fetal Membranes Rupture Test

Device Class : 1

Duns Number: 809524291

Premarket Exempt : No

Product Code : NQM

Prescription Use : Yes

Device Count : 1

ROM Plus®, Fetal Membranes Rupture Collection Kit - 00814247020444 Catalog Number :

Device Description : ROM Plus® Complete Kit Fetal Membranes Rupture Test

Device Class : 1

Duns Number: 809524291

Premarket Exempt : No

Product Code : NQM

Prescription Use : Yes

Device Count : 1

ROM Plus® Quality Control Kit - 00814247020451 Catalog Number :

Device Description : ROM Plus®, Quality Control for Fetal Membranes Rupture Test

Device Class : 1

Duns Number: 809524291

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

ROM Plus® Strip Quality Control - 00814247020468 Catalog Number :

Device Description : ROM Plus®, Easy Strip Quality Control for Fetal Membranes Rupture Test

Device Class : 1

Duns Number: 809524291

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

ClearView Uterine Manipulator - 00814247020475 Catalog Number :

Device Description : ClearView Uterine Manipulator, regular tip

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

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