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, Tonsil Suction (KCB) (10)

Premarket Exempt

No Yes

Clear

mytaMed - B35110402M0 Catalog Number : 1.04.02M

Device Description : Curved Sinus Suction, 2.5mm, Long, Malleable

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : KCB

Prescription Use : No

Device Count : 1

mytaMed - B351104030 Catalog Number : 1.04.03

Device Description : Curved Sinus Suction, 3.0mm, Short

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : KCB

Prescription Use : No

Device Count : 1

mytaMed - B351104040 Catalog Number : 1.04.04

Device Description : Curved Sinus Suction, 3.0mm, Long

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : KCB

Prescription Use : No

Device Count : 1

mytaMed - B35110404M0 Catalog Number : 1.04.04M

Device Description : Curved Sinus Suction, 3.0mm, Long, Malleable

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : KCB

Prescription Use : No

Device Count : 1

mytaMed - B351104050 Catalog Number : 1.04.05

Device Description : Curved Sinus Suction, 4.0mm, Short

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : KCB

Prescription Use : No

Device Count : 1

mytaMed - B351104060 Catalog Number : 1.04.06

Device Description : Curved Sinus Suction, 4.0mm, Long

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : KCB

Prescription Use : No

Device Count : 1

mytaMed - B35110406M0 Catalog Number : 1.04.06M

Device Description : Curved Sinus Suction, 4.0mm, Long, Malleable

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : KCB

Prescription Use : No

Device Count : 1

mytaMed - B351104110 Catalog Number : 1.04.11

Device Description : Curved Sinus Suction, Olive-Tip, Frazier Handle, 8 Fr, Short

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : KCB

Prescription Use : No

Device Count : 1

mytaMed - B351104120 Catalog Number : 1.04.12

Device Description : Curved Sinus Suction, Olive-Tip, Frazier Handle, 8 Fr, Long

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : KCB

Prescription Use : No

Device Count : 1

mytaMed - B351104130 Catalog Number : 1.04.13

Device Description : Curved Sinus Suction, Olive-Tip, Frazier Handle, 10 Fr, Short

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : KCB

Prescription Use : No

Device Count : 1

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