Primary Device ID | EMICTPENMP2 |
NIH Device Record Key | acc32a45-72e4-4c99-afc9-6bb288fb4c5f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Enamel Plus Stain & Instruments |
Version Model Number | TPENMP |
Catalog Number | TPENMP |
Company DUNS | 436661136 |
Company Name | MICERIUM SPA |
Device Count | 5 |
DM Exempt | true |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
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 | EMICTPENMP1 [Primary] |
HIBCC | EMICTPENMP2 [Unit of Use] |
EJB | Handle, Instrument, Dental |
Steralize Prior To Use | true |
Device Is Sterile | false |
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
Moist Heat or Steam Sterilization
[EMICTPENMP2]
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 |