UDI device identifier

TatumSurgical/D Implant D1S - Fin/4.0x4.0x16

UDI device identifier 00083208640162 · Suncoast Dental, Inc

Key facts

Primary DI 00083208640162
Brand name TatumSurgical/D Implant
Version or model D1S - Fin/4.0x4.0x16
Catalog number ID1S 4.0x4.0x16
Company Suncoast Dental, Inc
DUNS number 078352849
Product code DZE
GMDN term Blade endosteal dental implant, two-piece
Premarket submission K811923
Device class Class II
Single use Yes
Packaged sterile No
Implantable Yes
Publish date Oct 30, 2015
Version date Jan 3, 2023
Description D1S Fin Implant 4.0mm neck diameter, 4.0mm fin width and 16mm in length

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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