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

Electrocautery, Gynecologic (And Accessories) (HGI) (7) Sound, Uterine (HHM) (2) Cannula, Manipulator/Injector, Uterine (LKF) (1)

Premarket Exempt

No Yes

Clear

NA - 00852073002357 Catalog Number : TMI1155DM

Device Description : Balloon catheter with an insertion sheathfor hysterosalpingography and sonohyste Balloon catheter with an insertion sheathfor hysterosalpingography and sonohysterographyfor use with saline or water-based contrast media

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002364 Catalog Number : LE-10-203

Device Description : Round Loop,Loop Size: 20mm x 13mm

Device Class :

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

NA - 00852073002371 Catalog Number : LE-11-205

Device Description : Round Loop,Loop Size: 20mm x 15mm

Device Class :

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

NA - 00852073002388 Catalog Number : LE-12-251

Device Description : Round Loop,Loop Size: 25mm x 10mm

Device Class :

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

NA - 00852073002395 Catalog Number : LE-13-003

Device Class :

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

NA - 00852073002401 Catalog Number : US-01-025

Device Class : 1

Duns Number: 130814890

Premarket Exempt : Yes

Product Code : HHM

Prescription Use : Yes

Device Count : 1

NA - 00852073002418 Catalog Number : US-01-025P

Device Description : With Tip Markings

Device Class : 1

Duns Number: 130814890

Premarket Exempt : Yes

Product Code : HHM

Prescription Use : Yes

Device Count : 1

NA - 00852073002432 Catalog Number : LE-14-005

Device Class :

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

NA - 00852073002449 Catalog Number : LE-22-107

Device Description : Round Loop,Loop Size: 10mm x 7mm

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

NA - 00852073002456 Catalog Number : LE-23-155

Device Description : Round Loop,Loop Size: 15mm x 5mm

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

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