| Primary Device ID | 10815288011917 |
| NIH Device Record Key | 4fffec44-6f8a-4685-9776-3873bce831d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Insert, Maryland Dissector, Diamond Serrations |
| Version Model Number | ES0547 |
| Catalog Number | ES0547 |
| 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 | true |
| Serial Number | false |
| 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 | 10815288011917 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10815288011917]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-25 |
| Device Publish Date | 2016-08-31 |
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