T H S INTERNATIONAL, INC.

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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

Dislodger, Stone, Basket, Ureteral, Metal (FFL) (4)

Premarket Exempt

Clear

Accordion CoAx Stone Control Device - 00857252004009 Catalog Number : PA1305-01-15

Device Description : Accordion CoAx Stone Control Device

Device Class : 2

Duns Number: 101084796

Premarket Exempt : No

Product Code : FFL

Prescription Use : Yes

Device Count : 1

Accordion Stone Control Device; Accordion Stone Management Device - 00857252004016 Catalog Number :

Device Description : Accordion Stone Control Device; Accordion Stone Management Device

Device Class : 2

Duns Number: 101084796

Premarket Exempt : No

Product Code : FFL

Prescription Use : Yes

Device Count : 1

Accordion Stone Management Device - 00857252004023 Catalog Number : PA1205-06-10

Device Description : Accordion Stone Management Device

Device Class : 2

Duns Number: 101084796

Premarket Exempt : No

Product Code : FFL

Prescription Use : Yes

Device Count : 1

Accordion Piccolo Stone Management Device - 00857252004030 Catalog Number :

Device Description : Accordion Piccolo Stone Management Device

Device Class : 2

Duns Number: 101084796

Premarket Exempt : No

Product Code : FFL

Prescription Use : Yes

Device Count : 1

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