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

CATHETER, INTRAVASCULAR, DIAGNOSTIC (DQO) (10)

Premarket Exempt

No Yes

Clear

HEARTRAIL - 04987350383150 Catalog Number : GC-U6IL400A

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 - 04987350383174 Catalog Number : GC-U6IL450N

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 - 04987350383198 Catalog Number : GC-U6IL450A

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 - 04987350383235 Catalog Number : GC-U6IR100N

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 - 04987350383259 Catalog Number : GC-U6IR150N

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 - 04987350383273 Catalog Number : GC-U6IR200N

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 - 04987350423795 Catalog Number : GC-U6IR100A

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 - 04987350423818 Catalog Number : GC-U6IR200A

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 - 04987350423832 Catalog Number : GC-U6IL3G0A

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 - 04987350423856 Catalog Number : GC-U6IR150A

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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