| Primary Device ID | 20815288010719 |
| NIH Device Record Key | d8b4ea17-5e3f-4b5a-b787-236ebdec83de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AEM® Disposable Handswitching Handpiece with Rocker Switch |
| Version Model Number | ES1300 |
| Catalog Number | ES1300 |
| 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 | 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 | 10815288010712 [Primary] |
| GS1 | 20815288010719 [Package] Contains: 10815288010712 Package: [25 Units] In Commercial Distribution |
| GEI | Electrosurgical, Cutting & Coagulation & 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 | 2021-04-07 |
| Device Publish Date | 2016-08-31 |
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