UDI device identifier
Tatum Surgical Bone Fixation Screw Kit E-Z bone Fixation Screw Kit
UDI device identifier 00083208000003 · Suncoast Dental, Inc
Key facts
| Primary DI | 00083208000003 |
|---|---|
| Brand name | Tatum Surgical Bone Fixation Screw Kit |
| Version or model | E-Z bone Fixation Screw Kit |
| Catalog number | EZ-Bone Fixation Screw Kit |
| Company | Suncoast Dental, Inc |
| DUNS number | 078352849 |
| Product code | DZL |
| GMDN term | Craniofacial bone screw, non-bioabsorbable, non-sterile |
| Premarket submission | K141764 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Nov 13, 2020 |
| Version date | Feb 19, 2024 |
| Description | Bone Fixation Self-Drilling Screw kit with various size of bone screw for securing bone blocks Tatum EZ-Fixation Bone Screw Kit. Includes: Cassette, Driver handle, Driver Tip, Latch grip driver tip, (5) 8mm, (5) 10mm, (5) 12mm, and (3) 14mm Screws, 1.0 and 1.8 Drill. |
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: