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) (5) Electrocautery, Gynecologic (And Accessories) (HGI) (5)

Premarket Exempt

No Yes

Clear

NA - 00852073002463 Catalog Number : LE-24-201

Device Description : Round Loop,Loop Size: 20mm x 10mm

Device Class :

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

NA - 00852073002470 Catalog Number : LE-25-202

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

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

NA - 00852073002487 Catalog Number : LE-26-150

Device Description : Round Loop,Loop Size: 15mm x 10mm

Device Class :

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

NA - 00852073002494 Catalog Number : LE-27-157

Device Description : Round Loop,Loop Size: 15mm x 7mm

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

NA - 00852073002500 Catalog Number : LE-28-108

Device Description : Round Loop,Loop Size: 10mm x 8mm

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

NA - 00852073002517 Catalog Number : TMI1151

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002524 Catalog Number : TMI1152

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002531 Catalog Number : TMI1153

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002548 Catalog Number : TMI1154

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 :

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002555 Catalog Number : TMI1155

Device Class :

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

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