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) (6) TRANSDUCER, ULTRASONIC (JOP) (2) Dilator, catheter (GCC) (1) MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES) (MQH) (1)

Premarket Exempt

Clear

Byrd - 00827002205352 Catalog Number : LR-PPLBES-10.0-XL

Device Description : 10.0 Fr Byrd Dilator Sheath Set (B) Extra Long Polypropylene

Device Class : 1

Duns Number: 056867526

Premarket Exempt : No

Product Code : GCC

Prescription Use : Yes

Device Count : 1

Cook-Swartz - 00827002213630 Catalog Number : DP-SDP001

Device Description : Cook-Swartz Doppler Flow Probe Standard Cuff

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

Cook-Swartz - 00827002213647 Catalog Number : DP-CAB01

Device Description : Cook-Swartz Doppler Flow Probe Extension Cable

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

Evolution - 00827002237483 Catalog Number : LR-EVN-SH-9.0-RL

Device Description : Evolution Shortie 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 - 00827002237490 Catalog Number : LR-EVN-SH-11.0-RL

Device Description : Evolution Shortie 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

Steady Sheath - 00827002250826 Catalog Number : LR-TSS-9.0

Device Description : SteadySheath 9 Fr Evolution Tissue Stabilization Sheath

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

Steady Sheath - 00827002250833 Catalog Number : LR-TSS-11.0

Device Description : SteadySheath 11 Fr Evolution Tissue Stabilization Sheath

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

Steady Sheath - 00827002250840 Catalog Number : LR-TSS-13.0

Device Description : SteadySheath 13 Fr Evolution Tissue Stabilization Sheath

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

Cook Flexipet - 00827002260573 Catalog Number : K-FPIP-1600-10BS-5

Device Description : Flexipet Manipulation Pipette

Device Class :

Duns Number: 056867526

Premarket Exempt : No

Product Code : MQH

Prescription Use : Yes

Device Count : 10

Cook - 00827002265059 Catalog Number : LR-CRVFEM001

Device Description : Curved Inner Femoral Sheath

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

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