UDI device identifier

Tatum Surgical Integrity Analog ITI-OT XFer Screw 2.5

UDI device identifier 00083208925023 · Suncoast Dental, Inc

Key facts

Primary DI 00083208925023
Brand name Tatum Surgical Integrity
Version or model Analog ITI-OT XFer Screw 2.5
Catalog number Analog ITI-OT XFer Screw 2.5
Company Suncoast Dental, Inc
DUNS number 078352849
Product code NDP
GMDN term Dental prosthesis/implant abutment screw
Premarket submission K811923
Device class Class I
Single use Yes
Packaged sterile No
Implantable Yes
Publish date Feb 25, 2020
Version date Dec 9, 2020
Description Integrity Open Tray Transfer Screw 2.5mm, Fits transfers 6.0-8.0mm

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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