UDI device identifier

LunaGuard Nighttime Dental Guard

UDI device identifier 00033732010306 · McKeon Products, Inc.

Key facts

Primary DI 00033732010306
Brand name LunaGuard
Version or model Nighttime Dental Guard
Catalog number 1030
Company McKeon Products, Inc.
DUNS number 006522122
Product code OBR
GMDN term Mouthguard, reusable
Premarket submission K191033
Device class Unclassified
Single use No
Packaged sterile No
Implantable No
Publish date Oct 7, 2022
Version date Oct 17, 2022

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 10–99 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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