UDI device identifier

Tatum Surgical Bone Fixation Screw Bone Fix Scw 1.5x15mm

UDI device identifier 00083208006210 · Suncoast Dental, Inc

Key facts

Primary DI 00083208006210
Brand name Tatum Surgical Bone Fixation Screw
Version or model Bone Fix Scw 1.5x15mm
Catalog number Bone Fix Scw 1.5x15mm
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 Dec 24, 2019
Version date Feb 19, 2024
Description Bone Fixation Self-Drilling Screw for securing bone blocks

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:

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