| Primary Device ID | 16970754496156 |
| NIH Device Record Key | 4e36d995-c23f-43c0-bbfe-a2eda6f0a879 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orthopaedic Suction Set |
| Version Model Number | AEEFS1111 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06970754496159 [Primary] |
| GS1 | 16970754496156 [Package] Contains: 06970754496159 Package: [10 Units] In Commercial Distribution |
| JOL | Catheter And Tip, Suction |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-18 |
| Device Publish Date | 2023-09-08 |
| 16970754496156 - Orthopaedic Suction Set | 2023-09-18Sterile, single use, easyflow filtered suction system, for orthopaedic surgery. |
| 16970754496156 - Orthopaedic Suction Set | 2023-09-18 Sterile, single use, easyflow filtered suction system, for orthopaedic surgery. |
| 36970754494866 - Dynarex Corporation | 2023-02-13 |