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) (3) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (3) FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE (MBI) (2) BALLOON, EPISTAXIS (EMX) (1) INSTRUMENT, BENDING OR CONTOURING (HXP) (1)

Premarket Exempt

No Yes

Clear

Coblation - 00817470000481 Catalog Number : H0970-11

Device Description : O-RING CABLE

Device Class :

Duns Number: 109903521

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Coblation - 00817470000498 Catalog Number : H2000-20

Device Description : CATALOG BENDING TOOL

Device Class : 1

Duns Number: 109903521

Premarket Exempt : Yes

Product Code : HXP

Prescription Use : Yes

Device Count : 1

Rapid Rhino - 00817470000504 Catalog Number : RR 900

Device Description : RAPID RHINO 9CM INFATABLE DUAL BALLOON

Device Class : 1

Duns Number: 109903521

Premarket Exempt : Yes

Product Code : EMX

Prescription Use : Yes

Device Count : 1

N/A - 00817470000535 Catalog Number : 22-1011

Device Description : CAPS-LOCK CANNULA DRIVER 6MM X 70MM

Device Class : 1

Duns Number: 109903521

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Coblation - 00817470000542 Catalog Number : EIC9820-01

Device Description : EXCISE PDW WAND

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

N/A - 00817470000559 Catalog Number : 22-1012

Device Description : 55MM CAPS-LOCK CANNULA DRIVER LARGE BOR

Device Class : 1

Duns Number: 109903521

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MULTIFIX - 00817470000580 Catalog Number : OM-2300

Device Description : MULTIFIX S PEEK 5.5MM

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Coblation - 00817470000597 Catalog Number : EIC7071-01

Device Description : PROCISE MLW WAND

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

N/A - 00817470000603 Catalog Number : 22-1013

Device Description : 70MM CAPS-LOCK CANNULA DRIVER LARGE BOR

Device Class : 1

Duns Number: 109903521

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

SPEEDLOCK - 00817470000672 Catalog Number : OM-9756

Device Description : SPEEDLOCK PLUS KIT WITH MAGNUMWIRE WHITE SUTU SPEEDLOCK PLUS KIT WITH MAGNUMWIRE WHITE SUTURE CARTRIDGE

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

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