TERUMO 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

Endoscopic guidewire, gastroenterology-urology (OCY) (6) CATHETER, INTRAVASCULAR, DIAGNOSTIC (DQO) (4)

Premarket Exempt

No Yes

Clear

VISIGLIDE2 - 04953170358210 Catalog Number : G-260-3527S

Device Description : VISIGLIDE2 Single Use Guidewire

Device Class : 2

Duns Number: 690543319

Premarket Exempt : Yes

Product Code : OCY

Prescription Use : Yes

Device Count : 1

VISIGLIDE2 - 04953170358227 Catalog Number : G-260-3527A

Device Description : VISIGLIDE2 Single Use Guidewire

Device Class : 2

Duns Number: 690543319

Premarket Exempt : Yes

Product Code : OCY

Prescription Use : Yes

Device Count : 1

VISIGLIDE2 - 04953170358234 Catalog Number : G-260-2545S

Device Description : VISIGLIDE2 Single Use Guidewire

Device Class : 2

Duns Number: 690543319

Premarket Exempt : Yes

Product Code : OCY

Prescription Use : Yes

Device Count : 1

VISIGLIDE2 - 04953170358241 Catalog Number : G-260-2545A

Device Description : VISIGLIDE2 Single Use Guidewire

Device Class : 2

Duns Number: 690543319

Premarket Exempt : Yes

Product Code : OCY

Prescription Use : Yes

Device Count : 1

VISIGLIDE2 - 04953170358258 Catalog Number : G-260-3545S

Device Description : VISIGLIDE2 Single Use Guidewire

Device Class : 2

Duns Number: 690543319

Premarket Exempt : Yes

Product Code : OCY

Prescription Use : Yes

Device Count : 1

VISIGLIDE2 - 04953170358265 Catalog Number : G-260-3545A

Device Description : VISIGLIDE2 Single Use Guidewire

Device Class : 2

Duns Number: 690543319

Premarket Exempt : Yes

Product Code : OCY

Prescription Use : Yes

Device Count : 1

HEARTRAIL - 04987350383075 Catalog Number : GC-U6IL350N

Device Description : HEARTRAIL III Guiding Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

HEARTRAIL - 04987350383099 Catalog Number : GC-U6IL350A

Device Description : HEARTRAIL III Guiding Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

HEARTRAIL - 04987350383112 Catalog Number : GC-U6IL3G0N

Device Description : HEARTRAIL III Guiding Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

HEARTRAIL - 04987350383136 Catalog Number : GC-U6IL400N

Device Description : HEARTRAIL III Guiding Catheter

Device Class : 2

Duns Number: 690543319

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

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