| Primary Device ID | EZHIC2007601 |
| NIH Device Record Key | b0e66d9d-b75b-4088-aec8-c1bbe3baab4d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Colorbite Rock |
| Version Model Number | C200760 |
| Catalog Number | C200760 |
| 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 | EZHIC2007600 [Unit of Use] |
| HIBCC | EZHIC2007601 [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 |
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