| Primary Device ID | 19330944001916 |
| NIH Device Record Key | b9735b16-03d5-4124-a716-8dfe0d630a35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Trainer System™ |
| Version Model Number | T4K Phase 1 |
| Catalog Number | T4KSc |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 19330944001916 [Primary] |
| KMY | POSITIONER, TOOTH, PREFORMED |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-14 |
| Device Publish Date | 2025-05-06 |
| 19330944002043 | Infant Trainer Soft |
| 19330944002036 | Infant Trainer Soft |
| 19330944002029 | Infant Trainer Hard |
| 19330944002012 | Infant Trainer Hard |
| 19330944002005 | Infant Trainer Hard |
| 19330944001992 | T4K |
| 19330944001985 | T4K Phase 2 |
| 19330944001978 | T4K Phase 2 |
| 19330944001961 | T4K Phase 2 |
| 19330944001954 | T4K Phase 1 |
| 19330944001947 | T4K Phase 1 |
| 19330944001930 | T4K Phase 1 |
| 19330944001923 | T4K Phase 1 |
| 19330944001916 | T4K Phase 1 |
| 19330944001909 | T4K Phase 1 |
| 19330944001886 | T4K Broad |
| 19330944001879 | T4K Broad |
| 19330944001862 | T4B2 |
| 19330944001855 | T4B2 |
| 19330944001848 | T4B |
| 19330944001831 | T4B |
| 19330944001824 | T4A Phase 2 |
| 19330944001817 | T4A Phase 2 |
| 19330944001800 | T4A Phase 2 |
| 19330944001794 | T4A Phase 2 |
| 19330944001770 | T4A Phase 1 |
| 19330944001756 | T4A Phase 1 |
| 19330944001893 | T4K Phase 1 |
| 19330944001787 | T4A Phase 1 |
| 19330944001763 | T4A Phase 1 |