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

Cannula, ventricular (HCD) (3) BIT, DRILL (HTW) (2) CERCLAGE, FIXATION (JDQ) (2) INSTRUMENT, MANUAL, SURGICAL, GENERAL USE (MDM) (1) INSTRUMENT, SURGICAL, NON-POWERED (HAO) (1) TRAY, SURGICAL, INSTRUMENT (FSM) (1)

Premarket Exempt

No Yes

Clear

CODMAN SOFWIRE - 10705034002224 Catalog Number : 464010

Device Description : CODMAN SOF'WIRE Instrument Kit

Device Class : 1

Duns Number: 607846297

Premarket Exempt : Yes

Product Code : HAO

Prescription Use : Yes

Device Count : 1

CODMAN SOFWIRE - 10705034002231 Catalog Number : 464011

Device Description : CODMAN SOF'WIRE Cable Instrument Tray

Device Class : 1

Duns Number: 607846297

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

CODMAN SOFWIRE - 10705034002262 Catalog Number : 464019

Device Description : CODMAN SOFWIRE SS Single Cable with Leader, 1 Cinch, 1 Tightener

Device Class : 2

Duns Number: 607846297

Premarket Exempt : No

Product Code : JDQ

Prescription Use : Yes

Device Count : 1

CODMAN SOFWIRE - 10705034002286 Catalog Number : 464040

Device Description : CODMAN SOFWIRE SS Ti Single Cable with Leader, 1 Cinch, 1 Tightener

Device Class : 2

Duns Number: 607846297

Premarket Exempt : No

Product Code : JDQ

Prescription Use : Yes

Device Count : 1

SLIM-LOC - 10705034003184 Catalog Number : 465172

Device Description : SLIM-LOC ANTERIOR CERVICAL PLATE SYSTEM Drill for 12mm Screw

Device Class : 1

Duns Number: 607846297

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

SLIM-LOC - 10705034003191 Catalog Number : 465174

Device Description : SLIM-LOC ANTERIOR CERVICAL PLATE SYSTEM Drill for 14mm Screw

Device Class : 1

Duns Number: 607846297

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

SLIM-LOC - 10705034003238 Catalog Number : 465189

Device Description : SLIM-LOC ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER HANDLE

Device Class : 1

Duns Number: 607846297

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

CODMAN - 10886704000457 Catalog Number : 161015

Device Description : CODMAN ELSBERG Ventricular Cannula Silver 5 Fr.

Device Class : 1

Duns Number: 607846297

Premarket Exempt : Yes

Product Code : HCD

Prescription Use : Yes

Device Count : 1

CODMAN - 10886704000464 Catalog Number : 161016

Device Description : CODMAN ELSBERG Ventricular Cannula Silver 7 Fr.

Device Class : 1

Duns Number: 607846297

Premarket Exempt : Yes

Product Code : HCD

Prescription Use : Yes

Device Count : 1

CODMAN - 10886704000471 Catalog Number : 161017

Device Description : CODMAN ELSBERG Ventricular Cannula Silver 9 Fr.

Device Class : 1

Duns Number: 607846297

Premarket Exempt : Yes

Product Code : HCD

Prescription Use : Yes

Device Count : 1

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