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

Forceps, General & Plastic Surgery (GEN) (4) Source, Carrier, Fiberoptic Light (EQH) (2) Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (2) Holder, Ear Speculum (JYK) (1) Nasopharyngoscope (Flexible Or Rigid) (EOB) (1)

Premarket Exempt

No Yes

Clear

ENDO-EAR - B351EE03700 Catalog Number : EE-0370

Device Description : ENDO-EAR Endoscope, 3mm x 150mm, 70 Deg.

Device Class : 2

Duns Number: 015903922

Premarket Exempt : No

Product Code : EOB

Prescription Use : No

Device Count : 1

ENDO-EAR - B351EE10000 Catalog Number : EE-1000

Device Description : ENDO-EAR Endoscope Tray

Device Class : 2

Duns Number: 015903922

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

ENDO-EAR - B351EE10010 Catalog Number : EE-1001

Device Description : ENDO-EAR Instrument Tray

Device Class : 2

Duns Number: 015903922

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

mytaMed - B351FA10160 Catalog Number : FA1016

Device Description : Babcock Tissue Grasping Forceps, 16cm

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

mytaMed - B351GA42110 Catalog Number : GA4211

Device Description : Bishop-Harmon Forceps, 8.5cm, 0.4mm Serrated Tips

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

mytaMed - B351GA42130 Catalog Number : GA4213

Device Description : Bishop-Harmon Forceps, 8.5cm, 0.4mm 1X2 Teeth Tips

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

mytaMed - B351GC03800 Catalog Number : GC0380

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

mytaMed - B351ME16540 Catalog Number : M.E1654

Device Description : Lester Fixation Forceps, 1x2 Teeth

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : No

Device Count : 1

mytaMed - B351MLGA4X6AC0 Catalog Number : MLGA4X6AC

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

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : EQH

Prescription Use : No

Device Count : 1

mytaMed - B351MLGA4X6ST0 Catalog Number : MLGA4X6ST

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

Device Class : 1

Duns Number: 015903922

Premarket Exempt : Yes

Product Code : EQH

Prescription Use : No

Device Count : 1

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