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, catheter (GCC) (7) MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES) (MQH) (1) STYLET, CATHETER (DRB) (1) TRANSDUCER, ULTRASONIC (JOP) (1)

Premarket Exempt

Clear

Cook-Swartz - 00827002030145 Catalog Number : DP-SDP002

Device Description : Cook-Swartz Doppler Flow Probe Long Cuff

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : JOP

Prescription Use : Yes

Device Count : 1

Cook - 00827002180901 Catalog Number : K-MPIP-1035

Device Description : Micro-Injection Pipette

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : MQH

Prescription Use : Yes

Device Count : 1

Byrd - 00827002198593 Catalog Number : LR-PPLBES-10.0

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

Device Class : 1

Duns Number: 056867526

Premarket Exempt : No

Product Code : GCC

Prescription Use : Yes

Device Count : 1

Byrd - 00827002198609 Catalog Number : LR-PPLBES-11.5

Device Description : 11.5 Fr Byrd Dilator Sheath Set (C) Polypropylene

Device Class : 1

Duns Number: 056867526

Premarket Exempt : No

Product Code : GCC

Prescription Use : Yes

Device Count : 1

Byrd - 00827002198937 Catalog Number : LR-PPLBES-8.5

Device Description : 8.5 Fr Byrd Dilator Sheath Set (A) Polypropylene

Device Class : 1

Duns Number: 056867526

Premarket Exempt : No

Product Code : GCC

Prescription Use : Yes

Device Count : 1

Byrd - 00827002200005 Catalog Number : LR-TELSST002

Device Description : Byrd Telescoping Stainless Steel Dilator Sheath Set Size-B (Medium)

Device Class : 1

Duns Number: 056867526

Premarket Exempt : No

Product Code : GCC

Prescription Use : Yes

Device Count : 1

COOK - 00827002200067 Catalog Number : LR-STS001

Device Description : Stylet Wires

Device Class : 2

Duns Number: 056867526

Premarket Exempt : No

Product Code : DRB

Prescription Use : Yes

Device Count : 1

Byrd - 00827002205253 Catalog Number : LR-PPLBES-11.5-XL

Device Description : 11.5 Fr Byrd Dilator Sheath Set (C) Extra Long Polypropylene

Device Class : 1

Duns Number: 056867526

Premarket Exempt : No

Product Code : GCC

Prescription Use : Yes

Device Count : 1

Byrd - 00827002205260 Catalog Number : LR-PPLBES-13.0-XL

Device Description : 13.0 Fr Byrd Dilator Sheath Set (D) Extra Long Polypropylene

Device Class : 1

Duns Number: 056867526

Premarket Exempt : No

Product Code : GCC

Prescription Use : Yes

Device Count : 1

Byrd - 00827002205345 Catalog Number : LR-PPLBES-8.5-XL

Device Description : 8.5 Fr Byrd Dilator Sheath Set (A) Extra Long Polypropylene

Device Class : 1

Duns Number: 056867526

Premarket Exempt : No

Product Code : GCC

Prescription Use : Yes

Device Count : 1

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