UDI device identifier
Refilit 1
UDI device identifier 00010705400883 · MAJESTIC DRUG CO. INC.
Key facts
| Primary DI | 00010705400883 |
|---|---|
| Brand name | Refilit |
| Version or model | 1 |
| Company | MAJESTIC DRUG CO. INC. |
| DUNS number | 001496777 |
| Product code | EMA |
| GMDN term | Home-use dental cement |
| Premarket submission | K964773 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jul 27, 2016 |
| Version date | Jul 6, 2018 |
| Description | Refilit is a Eugenol free temporary dental cement for replacing lost fillings |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1,000+ GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: