FDA.reportPublic FDA data

Myo Munchee

Primary DI
09359648000011
Brand
Myo Munchee
Company
MYO MUNCHEE (OPERATIONS) PTY LTD
Model
1
Device description
MYO MUNCHEE MINI - reusable oral insert - 1 Piece
Published
2024-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IONExerciser, Non-Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IONExerciser, Non-MeasuringPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09359648000011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09359648000011093596480000119359648000011

GMDN Terms#

Term, Definition table
TermDefinition
Bite relief padA thin, plastic, horshoe-like wafer that is placed between the upper and lower sets of teeth and bitten down on, or chewed, to help relieve pain or discomfort after orthodontic treatment. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store out of direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61240775990hello@myomunchee.com

Regulatory Flags#

DUNS number
745300701
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09359648000004Myo Munchee1MM-BEB2-STD2024-06-12
09359648000028Myo Munchee12024-06-12
09359648000035Myo Munchee12024-06-12
09359648000042Myo Munchee12024-06-12
09359648000059Myo Munchee1CB-SKIT-0052024-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120077180311Elvistyromotion GmbHION2026-08-03
08054040401879BIKOORMESA SRLION2026-08-01
08054040401886BIKOORMESA SRLION2026-08-01
08054040401893BIKOORMESA SRLION2026-08-01
08054040401909BIKOORMESA SRLION2026-08-01
08054040401916BIKOORMESA SRLION2026-08-01
08054040401923BIKOORMESA SRLION2026-08-01
08054040401930BIKOORMESA SRLION2026-08-01
08054040401947BIKOORMESA SRLION2026-08-01
08054040401954BIKOORMESA SRLION2026-08-01
08054040401961BIKOORMESA SRLION2026-08-01
08054040401978BIKOORMESA SRLION2026-08-01
08054040401985BIKOORMESA SRLION2026-08-01
08054040401992BIKOORMESA SRLION2026-08-01
08054040402005BIKOORMESA SRLION2026-08-01
08054040402876BIKOORMESA SRLION2026-08-01
08054040403729BIKOORMESA SRLION2026-08-01
00851232007738OxyBREATH NON-MEASURING EXERCISERD R BURTON HEALTHCARE, LLCION2026-04-28
00851232007745OxyTrainer ADVANTAGED R BURTON HEALTHCARE, LLCION2026-04-28
08018294018009AirFeel IMTFLAEM NUOVA SPAION2026-02-18
18018294018006AirFeel IMTFLAEM NUOVA SPAION2026-02-18
00860014768620MouthflexINNOMOTIVE L.L.CION2026-02-11
08054040402029FRAME RUNNERORMESA SRLION2025-10-15
08054040402036FRAME RUNNERORMESA SRLION2025-10-15
08054040401275FRAME RUNNERORMESA SRLION2025-09-20
08054040401282FRAME RUNNERORMESA SRLION2025-09-20
08054040401299FRAME RUNNERORMESA SRLION2025-09-20
08054040401305FRAME RUNNERORMESA SRLION2025-09-20
08054040401312FRAME RUNNERORMESA SRLION2025-09-20
08054040401329FRAME RUNNERORMESA SRLION2025-09-20