Inrad

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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) (5) Instrument, Biopsy (KNW) (4) Set, I.V. Fluid Transfer (LHI) (1)

Premarket Exempt

Yes No

Clear

Inrad - 00817295020527 Catalog Number :

Device Description : Arterial, 1-part, 18 ga x 2 3/4"

Device Class : 2

Duns Number: 940023385

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Inrad - 00817295020534 Catalog Number :

Device Description : Flashback 1-part, 19 ga, 2 3/4"

Device Class : 2

Duns Number: 940023385

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Inrad - 00817295020541 Catalog Number :

Device Description : Arterial, 1-part, 19 ga x 2 3/4"

Device Class : 2

Duns Number: 940023385

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Inrad - 00817295020558 Catalog Number :

Device Description : IV Decanting Set

Device Class : 2

Duns Number: 940023385

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

Inrad - 00817295020596 Catalog Number :

Device Description : Modified Cournand 2-part, 18 ga, 2 1/8"

Device Class : 2

Duns Number: 940023385

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Inrad - 00817295020602 Catalog Number :

Device Description : Modified Cournand Needle, 19 ga, 2 1/8"

Device Class : 2

Duns Number: 940023385

Premarket Exempt : No

Product Code : DYB

Prescription Use : No

Device Count : 1

Inrad - 00817295020619 Catalog Number :

Device Description : SelectCore Variable Throw Biopsy Device 14 ga x 10 cm

Device Class : 2

Duns Number: 940023385

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

Inrad - 00817295020626 Catalog Number :

Device Description : SelectCore Variable Throw Biopsy Device 16 ga x 10 cm

Device Class : 2

Duns Number: 940023385

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

Inrad - 00817295020633 Catalog Number :

Device Description : SelectCore Variable Throw Biopsy Device 18 ga x 10 cm

Device Class : 2

Duns Number: 940023385

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

Inrad - 00817295020640 Catalog Number :

Device Description : SelectCore Variable Throw Biopsy Device 20 ga x 10 cm

Device Class : 2

Duns Number: 940023385

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

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