| Primary Device ID | 36970754494866 |
| NIH Device Record Key | f83323a0-510d-4fbc-ade4-82516457e88b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dynarex Corporation |
| Version Model Number | GC1957R08 |
| Company DUNS | 527142751 |
| Company Name | GCMEDICA ENTERPRISE LTD. (WUXI) |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 16970754494862 [Primary] |
| GS1 | 36970754494866 [Package] Contains: 16970754494862 Package: [10 Units] In Commercial Distribution |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-13 |
| Device Publish Date | 2023-02-04 |
| 16970754496156 - Orthopaedic Suction Set | 2023-09-18 Sterile, single use, easyflow filtered suction system, for orthopaedic surgery. |
| 36970754494866 - Dynarex Corporation | 2023-02-13 |
| 36970754494866 - Dynarex Corporation | 2023-02-13 |