SURGI SUPPLIES INTERNATIONAL PTY. LTD.

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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

Culdoscope (And Accessories) (HEW) (4) Cannula, Manipulator/Injector, Uterine (LKF) (2)

Premarket Exempt

Clear

ManipulatOR - 09349967000007 Catalog Number : UM-TV

Device Description : Uterine Manipulator

Device Class : 2

Duns Number: 753476779

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

ColpotomizOR Tube - 09349967000243 Catalog Number : C35-TV

Device Description : 35mm diameter trans-vaginal tube

Device Class : 2

Duns Number: 753476779

Premarket Exempt : No

Product Code : HEW

Prescription Use : Yes

Device Count : 1

ColpotomizOR Tube - 09349967000274 Catalog Number : C45-TV

Device Description : 45mm diameter trans-vaginal tube

Device Class : 2

Duns Number: 753476779

Premarket Exempt : No

Product Code : HEW

Prescription Use : Yes

Device Count : 1

ColpotomizOR Tube System - 09349967000304 Catalog Number : CTS35-TV

Device Description : 35mm diameter trans-vaginal tube and uterine manipulator

Device Class : 2

Duns Number: 753476779

Premarket Exempt : No

Product Code : HEW

Prescription Use : Yes

Device Count : 1

ColpotomizOR Tube System - 09349967000335 Catalog Number : CTS45-TV

Device Description : 45mm diameter trans-vaginal tube and uterine manipulator

Device Class :

Duns Number: 753476779

Premarket Exempt : No

Product Code : LKF, HEW

Prescription Use : Yes

Device Count : 1

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