UDI device identifier

Tatum Surgical-ITO Small Ball Analog Analog (SB) 3.0-5.0

UDI device identifier 00083208104619 · Suncoast Dental, Inc

Key facts

Primary DI 00083208104619
Brand name Tatum Surgical-ITO Small Ball Analog
Version or model Analog (SB) 3.0-5.0
Catalog number Analog ITO 3.0-5.0 (SB)
Company Suncoast Dental, Inc
DUNS number 078352849
Product code NDP
GMDN term Dental implant analog
Premarket submission K811923
Device class Class I
Single use Yes
Packaged sterile No
Implantable No
Publish date May 11, 2020
Version date May 19, 2020
Description Tatum One-Piece Analog for Small Ball Implants and abutments - size 3.0-5.0mm

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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