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) (6) Catheter, Assisted Reproduction (MQF) (2) Electrocautery, Gynecologic (And Accessories) (HGI) (2)

Premarket Exempt

No Yes

Clear

NA - 00852073002562 Catalog Number : TMI1156

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

NA - 00852073002579 Catalog Number : TMI1157

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002586 Catalog Number : TMI1295

Device Description : Intrauterine Insemination Catheter

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

NA - 00852073002593 Catalog Number : TMI1297

Device Description : Intrauterine Insemination Catheter

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

NA - 00852073002609 Catalog Number : TMI1160

Device Description : Includes 5F HS Catheter

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002616 Catalog Number : TMI1161

Device Description : Includes 7F HS Catheter

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002623 Catalog Number : TMI1162

Device Description : for Sonohysterography

Device Class :

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002630 Catalog Number : TMI6003

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002647 Catalog Number : LE-28-212

Device Description : Round Loop,Loop Size: 20mm x 12mm

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

NA - 00852073002654 Catalog Number : LE-29-505

Device Description : Square Loop,Loop Size: 5mm x 5mm

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

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