Myotalea® MTCBb

GUDID 19330944001565

MYOFUNCTIONAL RESEARCH CORPORATION PTY. LIMITED

Orthodontic retainer

• Primary Device ID: 19330944001565
• NIH Device Record Key: 8af7ca80-f79f-49b4-bcdf-5bcf22b9a2ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myotalea®
• Version Model Number: Myochew
• Catalog Number: MTCBb
• Company DUNS: 742030310
• Company Name: MYOFUNCTIONAL RESEARCH CORPORATION PTY. LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	19330944001565 [Primary]

FDA Product Code

• KMY: POSITIONER, TOOTH, PREFORMED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-14
• Device Publish Date: 2025-05-06

On-Brand Devices [Myotalea®]

• 19330944001671: TLP-S
• 19330944001664: TLP-S
• 19330944001640: TLP-H
• 19330944001633: TLJB
• 19330944001626: TLJ
• 19330944001619: TLJ
• 19330944001602: TLJ
• 19330944001589: Myochew
• 19330944001565: Myochew
• 19330944001541: LT
• 19330944001527: LST
• 19330944001503: LST
• 19330944001497: LST