| Primary Device ID | 06975683900050 |
| NIH Device Record Key | f52d8fd8-80d4-4e99-a527-c283807f4499 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ou Nuo |
| Version Model Number | T088RC125N |
| Company DUNS | 723688236 |
| Company Name | Changzhou Ou Nuo Medical Equipment Co., Ltd. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06975683900050 [Primary] |
| EBH | Material, Impression Tray, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-03 |
| Device Publish Date | 2023-02-23 |
| 06975683900012 | T040RC125N |
| 06975683900067 | T100RC125N |
| 06975683900050 | T088RC125N |
| 06975683900043 | T076RC125N |
| 06975683900036 | T063RC125N |
| 06975683900029 | T050RC125N |
| 06975683900098 | P040 |
| 06975683900296 | T100 |
| 06975683900289 | T088 |
| 06975683900272 | T076 |
| 06975683900265 | T063 |
| 06975683900258 | T050 |
| 06975683900241 | T040 |
| 06975683900234 | C200 |
| 06975683900227 | C150 |
| 06975683900210 | C100 |
| 06975683900203 | C088 |
| 06975683900197 | C076 |
| 06975683900180 | C063 |
| 06975683900173 | C050 |
| 06975683900166 | P200 |
| 06975683900159 | P150 |
| 06975683900142 | P100 |
| 06975683900135 | P088 |
| 06975683900128 | P076 |
| 06975683900111 | P063 |
| 06975683900104 | P050 |
| 06975683900074 | T076MC125N |