| Primary Device ID | 10815288014147 |
| NIH Device Record Key | b1e45245-aade-4d42-b1c2-d2e209dfe7d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AEM® Monitor |
| Version Model Number | EM3+ |
| Catalog Number | EM3+ |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10815288014147 [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 | 2022-02-14 |
| Device Publish Date | 2022-02-04 |
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| 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 |