Myo Munchee

Basic Information

• Brand Name: Myo Munchee
• Primary DI: 09359648000035
• Version / Model: 1
• Company Name: MYO MUNCHEE (OPERATIONS) PTY LTD
• Labeler DUNS: 745300701
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-12
• Public Version: 1
• Public Version Date: 2024-06-20
• Public Version Status: New
• Public Device Record Key: c596db4c-c17d-42c6-9cf2-e35b13afd5fd

Device Description

MYO MUNCHEE TWEEN - reusable oral insert - 1 Piece

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ION	Exerciser, Non-Measuring	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44858	Bite relief pad	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09359648000035	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8–14 yrs & adults with narrow jaw structure

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store out of direct sunlight