| Primary Device ID | EZHIC2020201 |
| NIH Device Record Key | ac90767e-6d20-4075-8d5f-d57e59d274b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elite HD+ Monophase Normal Set |
| Version Model Number | C202020 |
| Catalog Number | C202020 |
| Company DUNS | 432971034 |
| Company Name | ZHERMACK SPA |
| Device Count | 2 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Phone | +390425597611 |
| info@zhermack.com |
| Total Volume | 100 Milliliter |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EZHIC2020200 [Unit of Use] |
| HIBCC | EZHIC2020201 [Primary] |
| ELW | MATERIAL, IMPRESSION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-09 |
| EZHIC2020851 - Mixing Tips | 2022-06-23 Mixing Tips |
| EZHIC2020701 - Mixing Tips | 2022-06-22 Mixing Tip |
| EZHIC2020801 - Mixing Tips | 2022-06-22 Mixing Tip |
| EZHIC2020861 - Mixing Tips | 2022-06-22 Mixing Tips |
| EZHIC2020901 - Mixing Tips | 2022-06-22 Oral Tips |
| EZHIC2032331 - Mixing Tips | 2022-06-22 Mixing Tip |
| EZHIC2055001 - Mixing Tips | 2022-06-22 Mixing Tip |
| EZHIC2055301 - Dynamic-static Mixing Tips | 2022-06-22 Dynamic-static Mixing Tips |