CODMAN & SHURTLEFF, INC.

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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

Instrument, shunt system implantation (GYK) (3) DEVICE, MONITORING, INTRACRANIAL PRESSURE (GWM) (2) Electrosurgical, cutting & coagulation & accessories (GEI) (1) Shunt, central nervous system and components (JXG) (1)

Premarket Exempt

No Yes

Clear

CODMAN MICROSENSOR - 20886704042386 Catalog Number : 826638

Device Description : CODMAN MICROSENSOR Skull Bolt Kit Metal For Intraparenchymal Procedure

Device Class : 2

Duns Number: 607846297

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

CODMAN MICROSENSOR - 20886704042492 Catalog Number : 826653

Device Description : CODMAN MICROSENSOR Ventricular Catheter Kit With ICP Sensor Contains (1) Microse CODMAN MICROSENSOR Ventricular Catheter Kit With ICP Sensor Contains (1) Microsensor Ventricular Catheter, (1) Tunneling Trocar, (1) Catheter Anchoring Clip

Device Class : 2

Duns Number: 607846297

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

CODMAN - 20886704042720 Catalog Number : 831323

Device Description : CODMAN Peel-Away Catheter Introducer 9 Fr.

Device Class :

Duns Number: 607846297

Premarket Exempt : No

Product Code : GYK

Prescription Use : Yes

Device Count : 10

CODMAN - 20886704042737 Catalog Number : 831325

Device Description : CODMAN Peel-Away Catheter Introducer 12.5 FR.

Device Class :

Duns Number: 607846297

Premarket Exempt : No

Product Code : GYK

Prescription Use : Yes

Device Count : 10

CODMAN - 20886704042744 Catalog Number : 831326

Device Description : CODMAN Peel-Away Catheter Introducer 14 FR.

Device Class :

Duns Number: 607846297

Premarket Exempt : No

Product Code : GYK

Prescription Use : Yes

Device Count : 10

CODMAN - 20886704079894 Catalog Number : 821732C

Device Description : CODMAN External Drainage System Collection Bag

Device Class :

Duns Number: 607846297

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 5

CODMAN - 20886704081378 Catalog Number : 801130

Device Description : CODMAN Stylets (10 Units) for Irrigation Forceps

Device Class :

Duns Number: 607846297

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 10

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