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) (10)

Premarket Exempt

No Yes

Clear

Sheehy - 00613994176691 Catalog Number :

Device Description : VENT TUBE 1013302 10PK BUTTON PR 1.27 FP

Device Class : 2

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Donaldson - 00613994176707 Catalog Number :

Device Description : VENT TUBE 1015102 10PK DNLDSN PR 1.14 FP

Device Class : 2

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Shepard - 00613994176714 Catalog Number :

Device Description : VENT TUBE 1016102 10PK GROMT PR 1.14 FLP

Device Class : 2

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Sheehy - 00613994176738 Catalog Number :

Device Description : VENT TUBE MV13301 10PK BUTTON 1.27 FLPL

Device Class : 2

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Shepard - 00613994176745 Catalog Number :

Device Description : VENT TUBE MV16101 10PK GROMMET 1.14 FLPL

Device Class : 2

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Shepard - 00613994176752 Catalog Number :

Device Description : VENT TUBE MV16501 10PK GRMT WIRE 1.14 FP

Device Class : 2

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Reuter - 00613994176769 Catalog Number :

Device Description : VENT TUBE 1010103 50PK BOBB HOLE 1.14 FP

Device Class : 2

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Reuter - 00613994176776 Catalog Number :

Device Description : VENT TUBE 1010203 50PK BOBBIN 1.14 FLPL

Device Class : 2

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Sheehy - 00613994176783 Catalog Number :

Device Description : VENT TUBE 1013303 50PK BUTTON 1.27 FLPL

Device Class : 2

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Shepard - 00613994176790 Catalog Number :

Device Description : VENT TUBE 1016103 50PK GROMMET 1.14 FLPL

Device Class : 2

Duns Number: 835465063

Premarket Exempt : Yes

Product Code : ETD

Prescription Use : Yes

Device Count : 1

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