| Primary Device ID | EMICTLV11 |
| NIH Device Record Key | f783e438-19d6-49e0-b90e-61c6b19ecfc0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enamel Plus Stain & Instruments |
| Version Model Number | TLV1 |
| Catalog Number | TLV1 |
| Company DUNS | 436661136 |
| Company Name | MICERIUM SPA |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EMICTLV11 [Primary] |
| EJB | Handle, Instrument, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
[EMICTLV11]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-15 |
| Device Publish Date | 2023-05-05 |
| EMICTRAW2 | Enamel Plus Stain and Instruments Flexible white spatule |
| EMICTRAG2 | Enamel Plus Stain and Instruments Extra Flexible grey spatule |
| EMICTPENMS1 | Enamel Plus Stain and Instruments - 5 Spare blue rubber brush tips sterilizable - 190/180 degree |
| EMICTPENMP2 | 5 Spare blue rubber brush tips |
| EMICTLV21 | Enamel Plus Stain and Instruments Composite Modelling Instrument for Posteriors |
| EMICTLV11 | Enamel Plus Stain and Instruments Composite Modelling Instrument for Anteriors 1 - Fixed spatula |