| Primary Device ID | 19330944002142 |
| NIH Device Record Key | 0c8a4c71-953b-4bac-baaa-84c060ffc85f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Myoretainr® |
| Version Model Number | R |
| Catalog Number | MR1Lb |
| 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 | 19330944002142 [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 | 2025-05-21 |
| Device Publish Date | 2025-05-13 |
| 19330944002210 | RH |
| 19330944002203 | RH |
| 19330944002197 | RH |
| 19330944002180 | RH |
| 19330944002173 | R |
| 19330944002166 | R |
| 19330944002159 | R |
| 19330944002142 | R |
| 19330944002333 | RA |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MYORETAINR 79328805 not registered Live/Pending |
Myofunctional Research Corporation Pty.Limited 2021-11-25 |