The Trainer System™ T4KSb

GUDID 19330944001893

MYOFUNCTIONAL RESEARCH CORPORATION PTY. LIMITED

Orthodontic retainer
Primary Device ID19330944001893
NIH Device Record Key024de90d-4484-4289-8902-429f6ca19893
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe Trainer System™
Version Model NumberT4K Phase 1
Catalog NumberT4KSb
Company DUNS742030310
Company NameMYOFUNCTIONAL RESEARCH CORPORATION PTY. LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS119330944001893 [Primary]

FDA Product Code

KMYPOSITIONER, TOOTH, PREFORMED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-26
Device Publish Date2025-05-16

On-Brand Devices [The Trainer System™]

19330944002043Infant Trainer Soft
19330944002036Infant Trainer Soft
19330944002029Infant Trainer Hard
19330944002012Infant Trainer Hard
19330944002005Infant Trainer Hard
19330944001992T4K
19330944001985T4K Phase 2
19330944001978T4K Phase 2
19330944001961T4K Phase 2
19330944001954T4K Phase 1
19330944001947T4K Phase 1
19330944001930T4K Phase 1
19330944001923T4K Phase 1
19330944001916T4K Phase 1
19330944001909T4K Phase 1
19330944001886T4K Broad
19330944001879T4K Broad
19330944001862T4B2
19330944001855T4B2
19330944001848T4B
19330944001831T4B
19330944001824T4A Phase 2
19330944001817T4A Phase 2
19330944001800T4A Phase 2
19330944001794T4A Phase 2
19330944001770T4A Phase 1
19330944001756T4A Phase 1
19330944001893T4K Phase 1
19330944001787T4A Phase 1
19330944001763T4A Phase 1

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.