| Primary Device ID | 20888937021367 |
| NIH Device Record Key | d0e9d649-b9c3-4aa4-b8dc-66debce1d29a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Advincula Delineator Uterine Manipulator |
| Version Model Number | AD750SC-KE35 |
| 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 |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Outer Diameter | 3.5 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00888937021363 [Primary] |
| GS1 | 20888937021367 [Package] Contains: 00888937021363 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 | 2 |
| Public Version Date | 2018-12-07 |
| Device Publish Date | 2018-08-13 |
| 20888937021374 | Advincula Delineator Uterine Manipulator with 4.0cm Soft Koh-Efficient |
| 20888937021367 | Advincula Delineator Uterine Manipulator with 3.5cm Soft Koh-Efficient |
| 20888937021350 | Advincula Delineator Uterine Manipulator with 3.0cm Soft Koh-Efficient |
| 20888937021343 | Advincula Delineator Uterine Manipulator with 2.5cm Soft Koh-Efficient |