C R I

C R I

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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

Cannula, Manipulator/Injector, Uterine (LKF) (9) Electrocautery, Gynecologic (And Accessories) (HGI) (1)

Premarket Exempt

No Yes

Clear

NA - 00852073002043 Catalog Number : VMI1154

Device Description : Balloon catheter with an insertion sheathfor hysterosalpingography and sonohyste

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002050 Catalog Number : VMI1155

Device Description : Balloon catheter with an insertion sheathfor hysterosalpingography and sonohyste

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002067 Catalog Number : VMI1185

Device Description : Balloon catheter with an insertion sheathfor hysterosalpingography and sonohyste

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002074 Catalog Number : VMI1187

Device Description : Balloon catheter with an insertion sheathfor hysterosalpingography and sonohyste

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002081 Catalog Number : VMI1162

Device Description : for Sonohysterography

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002098 Catalog Number : VMI1156

Device Description : For use with HSG Catheters

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

MIller Advance Catheter - 00852073002203 Catalog Number : TMI2000

Device Description : Balloon catheter with an insertion sheathfor hysterosalpingography and saline in

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

MIller Advance Catheter - 00852073002210 Catalog Number : TMI2001

Device Description : Balloon catheter with an insertion sheathfor hysterosalpingography and saline in

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

MIller Advance Catheter - 00852073002227 Catalog Number : TMI2002

Device Description : Balloon catheter with an insertion sheathfor hysterosalpingography and saline in

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002234 Catalog Number : LE-01-104

Device Description : Square Loop,Loop Size: 10mm x 4mm

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

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