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

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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