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) (9) NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) (EOB) (1)

Premarket Exempt

No Yes

Clear

Sharpsite® - 00613994128270 Catalog Number :

Device Description : ENDOSCOPE 1880161X SHARPSITE X 2.7MM/30D

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

Armstrong - 00613994146069 Catalog Number :

Device Description : VENT TUBE 1081101 5PK ARMS MOD GROM 1.14

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Armstrong - 00613994146083 Catalog Number :

Device Description : VENT TUBE 1081102 10PK PR MOD GROM 1.14

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Paparella - 00613994146106 Catalog Number :

Device Description : VENT TUBE 1082201 5PK PAPA TYPE 1.14

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Paparella - 00613994146113 Catalog Number :

Device Description : VENT TUBE 1082202 10PK PAPA TYPE PR 1.14

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Paparella - 00613994146120 Catalog Number :

Device Description : VENT TUBE 1082203 50PK PAPA TYPE 1.14

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Sheehy - 00613994146144 Catalog Number :

Device Description : VENT TUBE 1083301 5PK SHEEHY TYPE 1.27

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Sheehy - 00613994146168 Catalog Number :

Device Description : VENT TUBE 1083302 10PK SHEEHY PAIR 1.27

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : ETD

Prescription Use : Yes

Device Count : 1

Sheehy - 00613994146175 Catalog Number :

Device Description : VENT TUBE 1083303 50PK SHEEHY TYPE 1.27

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : ETD

Prescription Use : Yes

Device Count : 1

NA - 00613994146182 Catalog Number :

Device Description : VENT TUBE 1084401 5PK GROMMET 1.27

Device Class : 2

Duns Number: 835465063

Premarket Exempt : No

Product Code : ETD

Prescription Use : Yes

Device Count : 1

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