| Primary Device ID | 20888937010828 |
| NIH Device Record Key | 70b30a89-e3d2-4b71-bdd7-5639a37d9238 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LEEP Radius Electrode |
| Version Model Number | R2010 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00888937010824 [Primary] |
| GS1 | 20888937010828 [Package] Contains: 00888937010824 Package: [5 Units] In Commercial Distribution |
| HGI | Electrocautery, Gynecologic (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 | 2019-02-07 |
| Device Publish Date | 2016-08-15 |
| 20888937010859 | LEEP Radius Electrode; 2.5cm x 1.0cm; 12cm Shaft |
| 20888937010842 | LEEP Radius Electrode; 2.0cm x 2.0cm; 12cm Shaft |
| 20888937010835 | LEEP Radius Electrode; 2.0cm x 1.5cm; 12cm Shaft |
| 20888937010828 | LEEP Radius Electrode; 2.0cm x 1.0cm; 12cm Shaft |
| 20888937010811 | LEEP Radius Electrode; 2.0cm x 0.8cm; 12cm Shaft |
| 20888937010804 | LEEP Radius Electrode; 1.5cm x 1.5cm; 12cm Shaft |
| 20888937010798 | LEEP Radius Electrode; 1.5cm x 0.7cm; 12cm Shaft |
| 20888937010781 | LEEP Radius Electrode;1.5cm x 0.5cm; 12cm Shaft |
| 20888937010774 | LEEP Radius Electrode; 1.0cm x 1.0cm; 12cm Shaft |
| 20888937010767 | LEEP Radius Electrode 1.0cm x 0.7cm; 12cm Shaft |