Mytamed, Inc.

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

Electrode, Needle (GXZ) (3) Tube, Ear Suction (JZF) (3) Apparatus, Electrosurgical (HAM) (1) Pick, Microsurgical Ear (JYT) (1) Probe, Ent (KAK) (1) Speculum, Ent (EPY) (1)

Premarket Exempt

No Yes

Clear

MytaMed - 00841019110201 Catalog Number :

Device Description : Malleable Monopolar Probe with 0.8mm Standard-Tip 100mm electrode (handle to tip Malleable Monopolar Probe with 0.8mm Standard-Tip 100mm electrode (handle to tip) 2m cable with DIN42802 connector

Device Class :

Duns Number: 015903922

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

MytaMed - 00841019110218 Catalog Number :

Device Description : Malleable Monopolar Probe with 3mm Ball-Tip 100mm electrode (handle to tip) 2m c Malleable Monopolar Probe with 3mm Ball-Tip 100mm electrode (handle to tip) 2m cable with DIN42802 connector

Device Class :

Duns Number: 015903922

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

MytaMed - 00841019110225 Catalog Number :

Device Description : Malleable Monopolar Probe with 2.25mm Ball-Tip 100mm electrode (handle to tip) 2 Malleable Monopolar Probe with 2.25mm Ball-Tip 100mm electrode (handle to tip) 2m cable with DIN42802 Connector

Device Class :

Duns Number: 015903922

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

MytaMed - 00841019110232 Catalog Number :

Device Description : Single Use Monopolar Suction Coagulator 10 French with 10 ft (3m) Monopolar Cord

Device Class :

Duns Number: 015903922

Premarket Exempt : No

Product Code : HAM

Prescription Use : Yes

Device Count : 1

mytaMed - B315656010 Catalog Number : 6.56.01

Device Description : Rosen Ear Needle, Straight Shaft, Strongly Curved Tip

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JYT

Prescription Use : No

Device Count : 1

mytaMed - B35105060 Catalog Number : 6.05.06

Device Description : Gruber Ear Specula, Oval, Adult, 3.2 x 4.7mm

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : EPY

Prescription Use : No

Device Count : 1

mytaMed - B351070700 Catalog Number : 7.07.70

Device Description : Ostium Seeker, Frontal

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : KAK

Prescription Use : No

Device Count : 1

mytaMed - B351100130 Catalog Number : 1.00.13

Device Description : Baron Suction Tube, 3 Fr

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

mytaMed - B351100140 Catalog Number : 1.00.14

Device Description : Baron Suction, 4 Fr

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

mytaMed - B351100150 Catalog Number : 1.00.15

Device Description : Baron Suction Tube, 5 Fr

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JZF

Prescription Use : No

Device Count : 1

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