Myobrace® MK2Sb

GUDID 19330944000537

MYOFUNCTIONAL RESEARCH CORPORATION PTY. LIMITED

Orthodontic retainer

• Primary Device ID: 19330944000537
• NIH Device Record Key: 18ec049d-a535-4270-9495-dee1edd7a40d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myobrace®
• Version Model Number: K2
• Catalog Number: MK2Sb
• 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	19330944000537 [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 [Myobrace®]

• 19330944002302: AA2
• 19330944002296: AA1
• 19330944002234: AA2
• 19330944002227: AA1
• 19330944001183: P-3N
• 19330944001176: P-3N
• 19330944001169: P-3H
• 19330944001145: P-3H
• 19330944001138: P-3H
• 19330944001114: P-3H
• 19330944001107: P-3
• 19330944001091: P-3
• 19330944001077: i-3N
• 19330944001060: i-3N
• 19330944001053: i-3N
• 19330944001046: i-3N
• 19330944001039: i-3N
• 19330944001015: i-3H
• 19330944000995: i-3
• 19330944000971: i-3
• 19330944000957: i-3
• 19330944000940: T4
• 19330944000933: T4
• 19330944000926: T3N
• 19330944000902: T3N
• 19330944000896: T3N
• 19330944000872: T3N
• 19330944000858: T3
• 19330944000834: T3
• 19330944000827: T3
• 19330944000803: T3
• 19330944000780: T2
• 19330944000773: T2
• 19330944000766: T1BWS
• 19330944000759: T1
• 19330944000742: T1
• 19330944000735: T1
• 19330944000711: K3 Broad
• 19330944000698: K2 Broad
• 19330944000681: K2 Broad
• 19330944000674: K2 Broad
• 19330944000650: K1 Broad
• 19330944000643: K1 Broad
• 19330944000636: K1 Broad
• 19330944000612: K3
• 19330944000605: K3
• 19330944000599: K3
• 19330944000575: K3
• 19330944000568: K3
• 19330944000551: K2