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

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (6) DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) (HBE) (2) NEUROSURGICAL PADDIE (HBA) (2)

Premarket Exempt

No Yes

Clear

CODMAN - 20886704004360 Catalog Number : 245466

Device Description : CODMAN Bipolar Cords - Disposable Bulk 50 Cords

Device Class :

Duns Number: 607846297

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 50

CODMAN MALIS - 20886704004377 Catalog Number : 245467

Device Description : CODMAN MALIS Integrated Irrigation Tubing and Bipolar Cord Set Bulk

Device Class :

Duns Number: 607846297

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 50

CODMAN MALIS - 20886704004384 Catalog Number : 245468

Device Description : CODMAN MALIS Integrated Irrigation Tubing and Bipolar Cord Set Bulk

Device Class :

Duns Number: 607846297

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 50

CODMAN - 20886704005145 Catalog Number : 261246

Device Description : CODMAN Cranio-blade Disposable

Device Class :

Duns Number: 607846297

Premarket Exempt : Yes

Product Code : HBE

Prescription Use : Yes

Device Count : 5

CODMAN - 20886704005152 Catalog Number : 261247

Device Description : CODMAN Wire Pass Drill Disposable

Device Class :

Duns Number: 607846297

Premarket Exempt : Yes

Product Code : HBE

Prescription Use : Yes

Device Count : 5

CODMAN MALIS - 20886704035807 Catalog Number : 801130

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

Device Class :

Duns Number: 607846297

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 10

CODMAN MALIS - 20886704035845 Catalog Number : 801163

Device Description : CODMAN MALIS Integrated Irrigation Tubing and Bipolar Cord Set

Device Class :

Duns Number: 607846297

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 10

CODMAN MALIS - 20886704036026 Catalog Number : 801189

Device Description : CODMAN MALIS Integrated Tube Set Unitized Plug

Device Class :

Duns Number: 607846297

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 10

CODMAN - 20886704036446 Catalog Number : 801396

Device Description : CODMAN Surgical Patties 5/16 Inch (0.79cm) Dia.

Device Class :

Duns Number: 607846297

Premarket Exempt : No

Product Code : HBA

Prescription Use : Yes

Device Count : 200

CODMAN - 20886704036453 Catalog Number : 801397

Device Description : CODMAN Surgical Patties 1/4 Inch x 1 1/2 Inches (0.64cm x 3.81cm)

Device Class :

Duns Number: 607846297

Premarket Exempt : No

Product Code : HBA

Prescription Use : Yes

Device Count : 200

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