| Primary Device ID | 30888937016568 |
| NIH Device Record Key | 02dc3c2d-967c-40a5-a58c-120656cc6cd3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GyneCath Catheter • 7F |
| Version Model Number | 19611 |
| Company DUNS | 801895244 |
| Company Name | Coopersurgical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| 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 | 00888937016567 [Primary] |
| GS1 | 20888937016561 [Package] Contains: 00888937016567 Package: [10 Units] In Commercial Distribution |
| GS1 | 30888937016568 [Package] Contains: 20888937016561 Package: [4 Units] In Commercial Distribution |
| LKF | Cannula, Manipulator/Injector, Uterine |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-22 |
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| 60888937027176 - ERPeak | 2024-04-18 IVD Sample kit |
| 60888937027183 - ERPeak | 2024-04-18 IVD Sample kit |
| 60888937027190 - ERPeak | 2024-04-18 IVD Sample kit |
| 60888937027206 - ERPeak | 2024-04-18 IVD Sample kit |
| 00888937026870 - Mara Console | 2024-03-21 Mara Console- Endometrial Ablation |
| 00888937023817 - K-Systems | 2024-02-27 L126 IVF, Standard Heat Right |