COOK INCORPORATED

Address:1100 W Morgan St,Spencer,IN,47460,US

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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

Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass (DTL) (4) DEVICE, PERCUTANEOUS, BIOPSY (MJG) (3) Trocar (DRC) (3)

Premarket Exempt

No Yes

Clear

Cook - 00827002000148 Catalog Number : DCHN-23-15.0

Device Description : Chiba Biopsy Needle

Device Class : 1

Duns Number: 042823948

Premarket Exempt : Yes

Product Code : MJG

Prescription Use : Yes

Device Count : 1

Cook - 00827002000155 Catalog Number : DCHN-23-20.0

Device Description : Chiba Biopsy Needle

Device Class : 1

Duns Number: 042823948

Premarket Exempt : Yes

Product Code : MJG

Prescription Use : Yes

Device Count : 1

Cook - 00827002000162 Catalog Number : DCHN-25-15.0

Device Description : Chiba Biopsy Needle

Device Class : 1

Duns Number: 042823948

Premarket Exempt : Yes

Product Code : MJG

Prescription Use : Yes

Device Count : 1

Cook - 00827002000179 Catalog Number : DCM-18-5.0

Device Description : Percutaneous Entry Thinwall Needle Two-Part Cook Modified

Device Class : 2

Duns Number: 042823948

Premarket Exempt : Yes

Product Code : DRC

Prescription Use : Yes

Device Count : 1

Cook - 00827002000186 Catalog Number : DCM-18-7.0

Device Description : Percutaneous Entry Thinwall Needle Two-Part Cook Modified

Device Class : 2

Duns Number: 042823948

Premarket Exempt : Yes

Product Code : DRC

Prescription Use : Yes

Device Count : 1

Cook - 00827002000193 Catalog Number : DCM-18-9.0

Device Description : Percutaneous Entry Thinwall Needle Two-Part Cook Modified

Device Class : 2

Duns Number: 042823948

Premarket Exempt : Yes

Product Code : DRC

Prescription Use : Yes

Device Count : 1

Cook - 00827002000308 Catalog Number : DPT5.3-15-P-FM

Device Description : Connecting Tube Female to Male Luer Lock

Device Class : 2

Duns Number: 042823948

Premarket Exempt : Yes

Product Code : DTL

Prescription Use : Yes

Device Count : 1

Cook - 00827002000339 Catalog Number : DPT5.3-30-P-FM

Device Description : Connecting Tube Female to Male Luer Lock

Device Class : 2

Duns Number: 042823948

Premarket Exempt : Yes

Product Code : DTL

Prescription Use : Yes

Device Count : 1

Cook - 00827002000353 Catalog Number : DPT5.3-60-P-FM

Device Description : Connecting Tube Female to Male Luer Lock

Device Class : 2

Duns Number: 042823948

Premarket Exempt : Yes

Product Code : DTL

Prescription Use : Yes

Device Count : 1

Cook - 00827002000360 Catalog Number : DPT5.3-90-P-FM

Device Description : Connecting Tube Female to Male Luer Lock

Device Class : 2

Duns Number: 042823948

Premarket Exempt : Yes

Product Code : DTL

Prescription Use : Yes

Device Count : 1

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