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

Source, Carrier, Fiberoptic Light (EQH) (6) Nasopharyngoscope (Flexible Or Rigid) (EOB) (3) Holder, Ear Speculum (JYK) (1)

Premarket Exempt

No Yes

Clear

BEAR - B351BMLGO4X7AC0 Catalog Number : MLGO4X7AC

Device Description : Fiberoptic Light Cable, 7.5', Olympus to ACMI

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : EQH

Prescription Use : No

Device Count : 1

BEAR - B351BMLGO4X7ST0 Catalog Number : MLGO4X7ST

Device Description : Fiberoptic Light Cable, 7.5', Olympus to Storz

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : EQH

Prescription Use : No

Device Count : 1

BEAR - B351BMLGS4X6AC0 Catalog Number : MLGS4X6AC

Device Description : Fiberoptic Light Cable, 6.0' Storz to ACMI

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : EQH

Prescription Use : No

Device Count : 1

BEAR - B351BMLGS4X6ST0 Catalog Number : MLGS4X6ST

Device Description : Fiberoptic Light Cable, 6.0' Storz to Storz

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : EQH

Prescription Use : No

Device Count : 1

BEAR - B351BMLGS4X7AC0 Catalog Number : MLGS4X7AC

Device Description : Fiberoptic Light Cable, 7.5', Storz to ACMI

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : EQH

Prescription Use : No

Device Count : 1

BEAR - B351BMLGS4X7ST0 Catalog Number : MLGS4X7ST

Device Description : Fiberoptic Light Cable, 7.5' Storz to Storz

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : EQH

Prescription Use : No

Device Count : 1

BEAR - B351BMN1699V0 Catalog Number : M.N1699.V

Device Description : Shea Ear Speculum Holder, Complete

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : JYK

Prescription Use : No

Device Count : 1

ENDO-EAR - B351EE03000 Catalog Number : EE-0300

Device Description : ENDO-EAR Endoscope, 3mm x 150mm, 0 Deg.

Device Class : 2

Duns Number: 015903922

Premarket Exempt : No

Product Code : EOB

Prescription Use : No

Device Count : 1

ENDO-EAR - B351EE03300 Catalog Number : EE-0330

Device Description : ENDO-EAR Endoscope, 3mm x 150mm, 30 Deg.

Device Class : 2

Duns Number: 015903922

Premarket Exempt : No

Product Code : EOB

Prescription Use : No

Device Count : 1

ENDO-EAR - B351EE03450 Catalog Number : EE-0345

Device Description : ENDO-EAR Endoscope, 3mm x 150mm, 45 Deg.

Device Class : 2

Duns Number: 015903922

Premarket Exempt : No

Product Code : EOB

Prescription Use : No

Device Count : 1

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