Mytamed, Inc.

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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, Ear Suction (JZF) (10)

Premarket Exempt

No Yes

Clear

mytaMed - B351112110 Catalog Number : 1.12.11

Device Description : Rosen Suction, 11 Gauge (3.02mm OD)

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

mytaMed - B351112120 Catalog Number : 1.12.12

Device Description : Rosen Suction, 12 Gauge (2.74mm OD)

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

mytaMed - B351112130 Catalog Number : 1.12.13

Device Description : Rosen Suction, 13 Gauge (2.39mm OD)

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

mytaMed - B351112140 Catalog Number : 1.12.14

Device Description : Rosen Suction, 14 Gauge (2.08mm OD)

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

mytaMed - B351112150 Catalog Number : 1.12.15

Device Description : Rosen Suction, 15 Gauge (1.82mm OD)

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

mytaMed - B351112160 Catalog Number : 1.12.16

Device Description : Rosen Suction, 16 Gauge (1.64mm OD)

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

mytaMed - B351112170 Catalog Number : 1.12.17

Device Description : Rosen Suction, 17 Gauge (1.46mm OD)

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

mytaMed - B351112180 Catalog Number : 1.12.18

Device Description : Rosen Suction, 18 Gauge (1.26mm OD)

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

mytaMed - B351112190 Catalog Number : 1.12.19

Device Description : Rosen Suction, 19 Gauge (1.05mm OD)

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

mytaMed - B351112200 Catalog Number : 1.12.20

Device Description : Rosen Suction, 20 Gauge (0.90mm OD)

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

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