FDA.reportPublic FDA data

mytaMed

Primary DI
B351640050
Brand
mytaMed
Company
Mytamed, Inc.
Model
6.40.05
Catalog number
6.40.05
Device description
Ear Syringe, Tip, Bulb
Published
2018-02-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KCPSyringe, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCPSyringe, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B351640050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ear irrigation kit, reusableA collection of items intended to be used to flush cerumen (ear wax) out of the ear canal during an ear/nose/throat (ENT) procedure. It consists of a manually-operated flushing device (e.g., spray bottle, syringe) and accessory items (e.g., a cup to collect used irrigation solution). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
015903922
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B351BMLGA4X6AC0BEARMLGA4X6ACMLGA4X6AC2021-02-09
B351BMLGA4X6ST0BEARMLGA4X6STMLGA4X6ST2021-02-09
B351BMLGA4X7AC0BEARMLGA4X7ACMLGA4X7AC2021-02-09
B351BMLGA4X7ST0BEARMLGA4X7STMLGA4X7ST2021-02-09
B351BMLGO4X6AC0BEARMLGO4X6ACMLGO4X6AC2021-02-09
B351BMLGO4X6ST0BEARMLGO4X6STMLGO4X6ST2021-02-09
B351BMLGO4X7AC0BEARMLGO4X7ACMLGO4X7AC2021-02-09
B351BMLGO4X7ST0BEARMLGO4X7STMLGO4X7ST2021-02-09
B351BMLGS4X6AC0BEARMLGS4X6ACMLGS4X6AC2021-02-09
B351BMLGS4X7AC0BEARMLGS4X7ACMLGS4X7AC2021-02-09
B351MLGA4X7AC0mytaMedMLGA4X7ACMLGA4X7AC2021-02-09
B351MLGO4X7AC0mytaMedMLGO4X7ACMLGO4X7AC2021-02-09
B351MLGO4X7ST0mytaMedMLGO4X7STMLGO4X7ST2021-02-09
B351MLGS4X7AC0mytaMedMLGS4X7ACMLGS4X7AC2021-02-09
B351MLGA4X7ST0mytaMedMLGA4X7STMLGA4X7ST2020-12-14
B351BMLGS4X6ST0BEARMLGS4X6STMLGS4X6ST2020-05-13
B351BMLGS4X7ST0BEARMLGS4X7STMLGS4X7ST2020-05-13
B351MLGS4X7ST0mytaMedMLGS4X7STMLGS4X7ST2020-05-13
B351MLGA4X6AC0mytaMedMLGA4X6ACMLGA4X6AC2018-02-16
B351MLGA4X6ST0mytaMedMLGA4X6STMLGA4X6ST2018-02-16

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