VORTEK SURGICAL, LLC

Address:7626 East 88th Place,Indianapolis,IN,46256,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

Drape, Surgical (KKX) (3)

Premarket Exempt

Clear

ENDODRAPE® - B27810689076068659 Catalog Number : 68659

Device Description : ENDODRAPE® Colonoscopy, 49" x 52"

Device Class : 2

Duns Number: 784805546

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

ENDODRAPE® - B27810689076068857 Catalog Number : 68857

Device Description : ENDODRAPE® Colonoscopy w/o ScopeGuard, 49"x 52"

Device Class : 2

Duns Number: 784805546

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

ENDODRAPE® - B27810689076069052 Catalog Number : 69052

Device Description : ENDODRAPE® Upper Endoscopy, 38" x 54"

Device Class :

Duns Number: 784805546

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

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