| Primary Device ID | EZHISP500531 |
| NIH Device Record Key | d2cea146-8780-4b47-9e47-00cf28217db8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | orthoprint |
| Version Model Number | SP50053 |
| Catalog Number | SP50053 |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com | |
| Phone | +390425597611 |
| info@zhermack.com |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Weight | 36 Gram |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 5 Degrees Celsius and 27 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EZHISP500530 [Unit of Use] |
| HIBCC | EZHISP500531 [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 |
| EZHISP500531 | Alginate impression material |
| EZHIC3021710 | Alginate impression material |
| EZHIC3021611 | Alginate impression material |
| EZHIC3021601 | Alginate impression material |
| EZHIC3021450 | Alginate impression material |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORTHOPRINT 75615632 2401382 Live/Registered |
Zhermack S.p.A. 1999-01-05 |