UDI device identifier
Bone Expander Screw Kit Bone Expander Screw Kit
UDI device identifier 00083208005558 · Suncoast Dental, Inc
Key facts
| Primary DI | 00083208005558 |
|---|---|
| Brand name | Bone Expander Screw Kit |
| Version or model | Bone Expander Screw Kit |
| Catalog number | Bone Expander Screw Kit (5) |
| Company | Suncoast Dental, Inc |
| DUNS number | 078352849 |
| Product code | DZN |
| GMDN term | Dental implant system |
| Premarket submission | K141764 |
| Device class | Class I |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | Yes |
| Publish date | Feb 3, 2021 |
| Version date | May 31, 2021 |
| Description | Bone Expander Screw Kit (5). Contains 2.6, 3.0, 3.4, 3.8 and 4.3mm Expanders, Ratchet Wrench, Ratchet Extender, Latch Grip Adapter, Thumb Wrench, and Box Used to create an osteotomy for Implant placement. |
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: