UDI device identifier
TatumSurgical/Ball Post for Integrity 3.7-4.5, 3.5 x 3.0mm Cuff Height 3.5 x 3mm Integrity ball post
UDI device identifier 00083208353086 · Suncoast Dental, Inc
Key facts
| Primary DI | 00083208353086 |
|---|---|
| Brand name | TatumSurgical/Ball Post for Integrity 3.7-4.5, 3.5 x 3.0mm Cuff Height |
| Version or model | 3.5 x 3mm Integrity ball post |
| Catalog number | PITI-BP 3.7- 4.5x3.0mm |
| 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 27, 2018 |
| Version date | Jan 22, 2021 |
| Description | Ball Post for Integrity 3.7-4.5, 3.5 x 3.0mm Cuff Height |
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: