| Primary Device ID | 04719894433400 |
| NIH Device Record Key | a6cf2f8e-e481-4a58-95cd-05b6fdaae0b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cooper Surgical |
| Version Model Number | 53404 |
| Company DUNS | 657769858 |
| Company Name | Bioteque Taiwan Ltd. |
| 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 | true |
| 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 | 04719894433400 [Primary] |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-19 |
| Device Publish Date | 2025-03-11 |
| 04719894433400 - Cooper Surgical | 2025-03-19 |
| 04719894433400 - Cooper Surgical | 2025-03-19 |
| 04719894433424 - Bioteque Taiwan Ltd. | 2025-03-18 |
| 04719894430003 - Bioteque Taiwan Ltd. | 2024-12-16 |
| 04719894430010 - Bioteque Taiwan Ltd. | 2024-12-16 |
| 04719894430027 - Bioteque Taiwan Ltd. | 2024-12-16 |
| 04719894430034 - Bioteque Taiwan Ltd. | 2024-12-16 |
| 04719894430041 - Bioteque Taiwan Ltd. | 2024-12-16 |
| 04719894430058 - Bioteque Taiwan Ltd. | 2024-12-16 |