| Primary Device ID | 06975683900227 | 
| NIH Device Record Key | c60ea644-e3fb-412d-8d64-eedc1db4de26 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Ou Nuo | 
| Version Model Number | C150 | 
| 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 | false | 
| 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 | 06975683900227 [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 | 2024-08-23 | 
| Device Publish Date | 2024-08-15 | 
| 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 |