Cook Vandergrift Inc.

Address:1186 Montgomery Lane,VANDERGRIFT,PA,15690,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

DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION (DRE) (4) MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES) (MQH) (4) TRANSDUCER, ULTRASONIC (JOP) (2)

Premarket Exempt

Clear

Cook Flexipet - 00827002460195 Catalog Number : K-FPIP-1140-10

Device Description : Flexipet Denuding Pipette

Device Class :

Duns Number: 056867526

Premarket Exempt : No

Product Code : MQH

Prescription Use : Yes

Device Count : 1

Cook Flexipet - 00827002460201 Catalog Number : K-FPIP-1300-10BS-5

Device Description : Flexipet Manipulation Pipette

Device Class :

Duns Number: 056867526

Premarket Exempt : No

Product Code : MQH

Prescription Use : Yes

Device Count : 10

Cook Flexipet - 00827002460218 Catalog Number : K-FPIP-1120-10BS-5

Device Description : Flexipet Denuding Pipette

Device Class :

Duns Number: 056867526

Premarket Exempt : No

Product Code : MQH

Prescription Use : Yes

Device Count : 10

Evolution - 00827002496514 Catalog Number : LR-EVN-SH-9.0

Device Description : Evolution Shortie 9 Fr Mechanical Dilator Sheath Set

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

Evolution - 00827002496521 Catalog Number : LR-EVN-SH-11.0

Device Description : Evolution Shortie 11 Fr Mechanical Dilator Sheath Set

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

Cook - 00827002553286 Catalog Number : DP-M350

Device Description : Blood Flow Monitor - Non-Sterile

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

Cook - 00827002554580 Catalog Number : DP-M350-CHG1

Device Description : Charger For Blood Flow Monitor - DP-M350 - Non-Sterile

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

Cook Flexipet - 10827002188782 Catalog Number : K-FPIP-1300-10BS

Device Description : Flexipet Manipulation Pipette

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : MQH

Prescription Use : Yes

Device Count : 1

Evolution - 10827002237374 Catalog Number : LR-EVN-9.0-RL

Device Description : Evolution RL 9 Fr Controlled-Rotation Dilator Sheath Set

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

Evolution - 10827002237466 Catalog Number : LR-EVN-11.0-RL

Device Description : Evolution RL 11 Fr Controlled-Rotation Dilator Sheath Set

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

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