Oto-Med, Inc.

Address:1090 Empire Dr.,Lake Havasu City,AZ,86404,US

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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

Dressing, Compression (MHW) (3) Bone Particle Collector (MXP) (2) Drape, Surgical, Exempt (PUI) (2) Apparatus, Suction, Operating-Room, Wall Vacuum Powered (GCX) (1) Blower, Powder, Ent (KCL) (1) Trap, Sterile Specimen (BYZ) (1)

Premarket Exempt

Yes

Clear

GLASSCOCK® EAR DRESSING, ADULT - 00850000126015 Catalog Number :

Device Description : GLASSCOCK® EAR DRESSING, ADULT

Device Class :

Duns Number: 059817742

Premarket Exempt : Yes

Product Code : MHW

Prescription Use : Yes

Device Count : 1

GLASSCOCK® EAR DRESSING, PEDIATRIC - 00850000126022 Catalog Number :

Device Description : GLASSCOCK® EAR DRESSING, PEDIATRIC

Device Class :

Duns Number: 059817742

Premarket Exempt : Yes

Product Code : MHW

Prescription Use : Yes

Device Count : 1

HEAD & NECK PRESSURE DRESSING - 00850000126039 Catalog Number :

Device Description : HEAD & NECK PRESSURE DRESSING

Device Class :

Duns Number: 059817742

Premarket Exempt : Yes

Product Code : MHW

Prescription Use : Yes

Device Count : 1

SHEEHY BONE DUST COLLECTOR - 00850000126046 Catalog Number :

Device Description : SHEEHY BONE DUST COLLECTOR

Device Class : 1

Duns Number: 059817742

Premarket Exempt : Yes

Product Code : MXP

Prescription Use : Yes

Device Count : 1

SHEEHY-HOUSE POWDER INSUFFLATOR - 00850000126053 Catalog Number :

Device Description : SHEEHY-HOUSE POWDER INSUFFLATOR

Device Class : 1

Duns Number: 059817742

Premarket Exempt : Yes

Product Code : KCL

Prescription Use : Yes

Device Count : 1

COX BONE DUST COLLECTOR - 00850000126060 Catalog Number :

Device Description : COX BONE DUST COLLECTOR

Device Class : 1

Duns Number: 059817742

Premarket Exempt : Yes

Product Code : MXP

Prescription Use : Yes

Device Count : 1

spineX BONE DUST COLLECTOR - 00850000126077 Catalog Number :

Device Description : spineX BONE DUST COLLECTOR

Device Class : 2

Duns Number: 059817742

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : Yes

Device Count : 1

GLASSCOCK OTOLOGY SURGERY DRAPE - 00850000126084 Catalog Number :

Device Description : GLASSCOCK OTOLOGY SURGERY DRAPE

Device Class :

Duns Number: 059817742

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

GLASSCOCK NEUROTOLOGY SURGERY DRAPE - 00850000126091 Catalog Number :

Device Description : GLASSCOCK NEUROTOLOGY SURGERY DRAPE

Device Class :

Duns Number: 059817742

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

SAFETRAP TISSUE COLLECTOR - 00850000126107 Catalog Number :

Device Description : SAFETRAP TISSUE COLLECTOR

Device Class : 2

Duns Number: 059817742

Premarket Exempt : Yes

Product Code : BYZ

Prescription Use : Yes

Device Count : 1

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