MEDTRONIC XOMED, INC.

Address:950 Flanders Rd,Mystic,CT,06355,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

TUBE, TYMPANOSTOMY (ETD) (8) BUR, EAR, NOSE AND THROAT (EQJ) (1) ELECTRODE, NEEDLE (GXZ) (1) Electrode, needle, diagnostic electromyograph (IKT) (1) Electromyograph, diagnostic (IKN) (1)

Premarket Exempt

No Yes

Clear

NA - 00613994146205 Catalog Number :

Device Description : VENT TUBE 1084402 10PK GROMMET PAIR 1.27

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Shepard - 00613994146274 Catalog Number :

Device Description : VENT TUBE 1086601 5PK SHEP GROM 1.02

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Goode T-Tube® - 00613994146298 Catalog Number :

Device Description : VENT TUBE 1087701 5PK GOODE T 1.14X12MM

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Goode T-Tube® - 00613994146304 Catalog Number :

Device Description : VENT TUBE 1087702 10PK GOODE T PR 1.14

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : ETD

Prescription Use : Yes

Device Count : 1

ViSAO® - 00613994151896 Catalog Number :

Device Description : BUR 31180698E VISAO CVD DIAMD .6X98MM L

Device Class : 1

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : EQJ

Prescription Use : Yes

Device Count : 1

Accuguide® - 00613994161635 Catalog Number :

Device Description : SOFTWARE 8263005 ACCUGUIDE MONIT V2.0 CD

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : IKN, GXZ, IKT

Prescription Use : Yes

Device Count : 1

Reuter - 00613994176523 Catalog Number :

Device Description : VENT TUBE 1010101 5PK BOBB HOLE 1.14 FLP

Device Class : 2

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Reuter - 00613994176530 Catalog Number :

Device Description : VENT TUBE 1010201 5PK BOBBIN 1.14 FLPL

Device Class : 2

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Reuter - 00613994176547 Catalog Number :

Device Description : VENT TUBE 1010301 5PK BOBB WIRE 1.14 FLP

Device Class : 2

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Sheehy - 00613994176561 Catalog Number :

Device Description : VENT TUBE 1013301 5PK BUTTON 1.27 FLPL

Device Class : 2

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : ETD

Prescription Use : Yes

Device Count : 1

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