| Primary Device ID | 00888937013801 |
| NIH Device Record Key | 60e0f95b-ba54-483e-88b5-2543ee95f9d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Advincula Delineator™ Uterine Manipulator with 2.5 cm Ultem® Koh-Efficient® |
| Version Model Number | AD750-KE25 |
| 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 | 00888937013801 [Primary] |
| GS1 | 20888937013805 [Package] Package: [3 Units] In Commercial Distribution |
| HEW | Culdoscope (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-12-07 |
| Device Publish Date | 2016-10-24 |
| 00888937018240 - Lone Star® IRI Delivery | 2024-07-01 Lone Star® IRI Delivery Tube Replacement |
| 00888937026597 - LEEP PRECISION™ Smoke Evacuator | 2024-06-25 LEEP PRECISION™ Smoke Evacuator (230 VAC) |
| 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 |