FDA.report

mytaMed

Primary DI
B351640020
Brand
mytaMed
Company
Mytamed, Inc.
Model
6.40.02
Catalog number
6.40.02
Device description
Ear Syringe, Set Complete, 75ml
Published
2018-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KCPSyringe, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KCPSyringe, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B351640020PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
015903922
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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