| Primary Device ID | EMICCOSM101A1 |
| NIH Device Record Key | c265623b-e340-404d-94d2-d8b10eac4a83 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ena Etch ® |
| Version Model Number | COSM101A |
| Catalog Number | COSM101A |
| Company DUNS | 436661136 |
| Company Name | MICERIUM SPA |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Total Volume | 8 Milliliter |
| Storage Environment Temperature | Between 3 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EMICCOSM101A1 [Primary] |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-24 |
| Device Publish Date | 2018-11-21 |
| EMICCOSM101B1 | ENA-ETCH Etching gel 37% phosphoric acid Kit 2 x COS101 1 x COS101B |
| EMICCOSM101A1 | ENA-ETCH Etching gel 37% phosphoric acid Kit 4 x COS101 ENA-ETCH Etching gel 37% 2 ml |
| EMICCOSM1011 | ENA-ETCH Etching gel 37% phosphoric acid Kit 2 x COS101 ENA-ETCH Etching gel 37% 2 ml |
| EMICCOS101B0 | ENA-ETCH Etching gel 37% phosphoric acid 25ml |
| EMICCOS1010 | ENA-ETCH Etching gel 37% phosphoric acid 2ml |