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) (7) Arthroscope (HRX) (2) SPLINT, INTRANASAL SEPTAL (LYA) (1)

Premarket Exempt

No Yes

Clear

KVAC - 00817470000252 Catalog Number : ASHA5050-01

Device Description : AMBIENT KVAC IFS WAND

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

KVAC - 00817470000290 Catalog Number : ASC5050-01

Device Description : KVAC STANDARD WAND

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

Coblation - 00817470000313 Catalog Number : EIC8875-01

Device Description : ENT COBLATOR II, PROCISE EZ VIEW

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Coblation - 00817470000368 Catalog Number : EIC8872-01

Device Description : ENT COBLATOR II, PROCISE XP WAND

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Coblation - 00817470000382 Catalog Number : EIC6895-01

Device Description : TURBINATOR WAND

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Sinu-foam - 00817470000412 Catalog Number : RR 650

Device Description : SINU FOAM

Device Class : 1

Duns Number: 109903521

Premarket Exempt : Yes

Product Code : LYA

Prescription Use : Yes

Device Count : 1

Coblation - 00817470000436 Catalog Number : ASHA4730-01

Device Description : AMBIENT HIPVAC 50 IFS

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Coblation - 00817470000443 Catalog Number : EIC7070-01

Device Description : PROCISE LW WAND

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Coblation - 00817470000450 Catalog Number : EIC8870-01

Device Description : PROCISE EZ WAND

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Coblation - 00817470000467 Catalog Number : H0970-02

Device Description : PATIENT CABLE W/CAPS

Device Class : 2

Duns Number: 109903521

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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