UDI device identifier
Tatum Surgical/Integrity Implant Integrity/8.0x20
UDI device identifier 00083208480201 · Suncoast Dental, Inc
Key facts
| Primary DI | 00083208480201 |
|---|---|
| Brand name | Tatum Surgical/Integrity Implant |
| Version or model | Integrity/8.0x20 |
| Catalog number | ITI 8.0 x 20mm |
| Company | Suncoast Dental, Inc |
| DUNS number | 078352849 |
| Product code | DZE |
| GMDN term | Screw endosteal dental implant, two-piece |
| Premarket submission | K811923 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | Yes |
| Publish date | Jul 18, 2018 |
| Version date | Jun 1, 2020 |
| Description | Integrity Dental Implant 8.0mm in diameter and 20mm in length |
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: