Smith & Nephew, Inc.

Smith & Nephew, Inc.

Address:7135 Goodlett Farms Pkwy,Cordova,TN,38016,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

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (4) BIT, DRILL (HTW) (3) ACCESSORIES,ARTHROSCOPIC (NBH) (1) BRACE, DRILL (HXY) (1) PASSER (HWQ) (1)

Premarket Exempt

No Yes

Clear

Coblation - 00817470000016 Catalog Number : ASHA4250-01

Device Description : AMBIENT SUPER TURBOVAC 90 IFS

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Coblation - 00817470000030 Catalog Number : A1325-01

Device Description : 2.5 MM NON-INTEGRATED CABLE WAND NON-ICW, RIG 2.5 MM NON-INTEGRATED CABLE WAND NON-ICW, RIGHT ANGLE 90 DEGREE

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

N/A - 00817470000054 Catalog Number : 21-8015

Device Description : 7.5MM TIBIAL DRILL

Device Class : 1

Duns Number: 109903521

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

N/A - 00817470000061 Catalog Number : 21-8016

Device Description : 8.0MM TIBIAL DRILL

Device Class : 1

Duns Number: 109903521

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

N/A - 00817470000078 Catalog Number : 21-8022

Device Description : TRANS TIBIAL CENTER GUIDE

Device Class : 1

Duns Number: 109903521

Premarket Exempt : Yes

Product Code : HXY

Prescription Use : Yes

Device Count : 1

Coblation - 00817470000115 Catalog Number : A3625-01

Device Description : 2.5MM DOME 30 DEGREE

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Coblation - 00817470000122 Catalog Number : A2630-01

Device Description : 3.0MM BEVEL 30 DEGREE

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

FIRSTPASS - 00817470000160 Catalog Number : 22-4035

Device Description : FIRSTPASS SUTURE PASSER

Device Class : 1

Duns Number: 109903521

Premarket Exempt : Yes

Product Code : HWQ

Prescription Use : Yes

Device Count : 1

FIRSTPASS - 00817470000184 Catalog Number : 22-4036

Device Description : FIRSTPASS NEEDLE AND SUTURE CAPTURE, 5 PER BOX

Device Class : 1

Duns Number: 109903521

Premarket Exempt : Yes

Product Code : NBH

Prescription Use : Yes

Device Count : 1

N/A - 00817470000191 Catalog Number : 21-8046

Device Description : 7MM FEMORAL LOW PROFILE ACORN DRILL

Device Class : 1

Duns Number: 109903521

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

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