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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

Catheter, Assisted Reproduction (MQF) (6) Cannula, Manipulator/Injector, Uterine (LKF) (3)

Premarket Exempt

No Yes

Clear

NA - 00852073002890 Catalog Number : TMI1189

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 - 00852073002920 Catalog Number : TMI1192

Device Description : Intrauterine Insemination Catheter

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

NA - 00852073002937 Catalog Number : TMI1193

Device Description : Intrauterine Insemination Catheter

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

NA - 00852073002944 Catalog Number : TMI1194

Device Description : Intrauterine Insemination Catheter

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

NA - 00852073002951 Catalog Number : TMI1195

Device Description : Intrauterine Insemination Catheter

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

NA - 00852073002968 Catalog Number : TMI1196

Device Description : Intrauterine Insemination Catheter

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

NA - 00852073002975 Catalog Number : TMI1197

Device Description : Intrauterine Insemination Catheter

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : MQF

Prescription Use : Yes

Device Count : 1

NA - 00852073002982 Catalog Number : TMI1198

Device Description : Includes 5F Shapeable HS Catheter

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

NA - 00852073002999 Catalog Number : TMI1199

Device Description : Includes 7F Shapeable HS Catheter

Device Class : 2

Duns Number: 130814890

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

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