Sterigear, LLC

Address:362 S University Ave,Provo,UT,84601,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

Urinary drainage collection kit, for indwelling catheter (FCN) (6)

Premarket Exempt

Yes

Clear

SteriGear - 00851616002007 Catalog Number :

Device Description : The Fig Leaf 10270

Device Class : 2

Duns Number: 809509297

Premarket Exempt : Yes

Product Code : FCN

Prescription Use : No

Device Count : 1

SteriGear - 00851616002014 Catalog Number :

Device Description : Fig Leaf Foley Catheter Kit 16 Fr. 10274

Device Class :

Duns Number: 809509297

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

SteriGear - 00851616002021 Catalog Number :

Device Description : Fig Leaf Lite 10273

Device Class : 2

Duns Number: 809509297

Premarket Exempt : Yes

Product Code : FCN

Prescription Use : No

Device Count : 1

SteriGear - 00851616002038 Catalog Number :

Device Description : Fig Leaf Leg Bag 10272

Device Class : 2

Duns Number: 809509297

Premarket Exempt : Yes

Product Code : FCN

Prescription Use : No

Device Count : 1

SteriGear - 00851616002076 Catalog Number :

Device Description : Fig Leaf Foley Catheter Kit 18 Fr. 10279

Device Class :

Duns Number: 809509297

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

SteriGear - 00851616002465 Catalog Number :

Device Description : Fig Leaf 1000ml Leg Bag 10280

Device Class : 2

Duns Number: 809509297

Premarket Exempt : Yes

Product Code : FCN

Prescription Use : No

Device Count : 1

SteriGear - 00851616002564 Catalog Number :

Device Description : Twin Fig Leaf 2000ml 10286

Device Class : 2

Duns Number: 809509297

Premarket Exempt : Yes

Product Code : FCN

Prescription Use : No

Device Count : 1

SteriGear - 00851616002571 Catalog Number :

Device Description : Fig Leaf Low 15 1500ml 10287

Device Class : 2

Duns Number: 809509297

Premarket Exempt : Yes

Product Code : FCN

Prescription Use : No

Device Count : 1

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