TERUMO MEDICAL CORPORATION

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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

INTRODUCER, CATHETER (DYB) (10)

Premarket Exempt

Clear

DESTINATION - 00389701006260 Catalog Number : RSR11

Device Description : DESTINATION Renal Guiding Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

DESTINATION - 00389701006277 Catalog Number : RSR12

Device Description : DESTINATION Renal Guiding Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

DESTINATION - 00389701006796 Catalog Number : RSC01

Device Description : DESTINATION Carotid Guiding Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

DESTINATION - 00389701006802 Catalog Number : RSC02

Device Description : DESTINATION Carotid Guiding Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

DESTINATION - 00389701006970 Catalog Number : RSR13

Device Description : DESTINATION Renal Guiding Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

DESTINATION - 00389701006987 Catalog Number : RSR15

Device Description : DESTINATION Renal Guiding Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

DESTINATION - 00389701006994 Catalog Number : RSR17

Device Description : DESTINATION Renal Guiding Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

DESTINATION - 00389701007007 Catalog Number : RSR19

Device Description : DESTINATION Renal Guiding Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

DESTINATION - 00389701007168 Catalog Number : RSR14

Device Description : DESTINATION Renal Guiding Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

DESTINATION - 00389701007175 Catalog Number : RSR16

Device Description : DESTINATION Renal Guiding Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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