| Primary Device ID | 10815288014154 |
| NIH Device Record Key | 6bc8a61f-3380-448e-8fc9-abce77d9920d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EM3 Monopolar Adapter, Universal |
| Version Model Number | EM3-60+ |
| Catalog Number | EM3-60+ |
| Company DUNS | 612250175 |
| Company Name | ENCISION, 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 10815288014154 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-04 |
| Device Publish Date | 2022-01-27 |
| 10815288014314 - Single Action Needle Holder, Ratcheting Handle, With Rotation, 35cm | 2024-02-15 |
| 10815288014345 - Round Tip Allis Grasping Forcep, Ratcheting Handle, With Rotation, 35cm | 2024-02-15 |
| 10815288011795 - 5mm Cobra Jaw Grasping Forcep, Ratcheting Handle, With Rotation | 2024-02-08 |
| 10815288013799 - Fenestrating Grasping Forcep, 35cm | 2024-02-08 Fenestrating Grasping Forcep, 35cm with Rotating/Ratcheting Handle |
| 10815288013805 - Allis Forcep, 35cm | 2024-02-08 Allis Forcep, 35cm with Rotating/Ratcheting Handle |
| 10815288013812 - Fenestrated Bowel Grasper, 35cm, 20mm Jaw | 2024-02-08 Fenestrated Bowel Grasper, 35cm, 20mm Jaw |
| 10815288013829 - Traumatic Grasper, 35cm | 2024-02-08 Traumatic Grasper, 35cm with Rotating/Ratcheting Handle |
| 10815288014253 - Rounded Maryland Dissector | 2023-06-29 |