UDI device identifier

Spore Check System Dual-Spore

UDI device identifier 00016724410001 · OSHA REVIEW INC

Key facts

Primary DI 00016724410001
Brand name Spore Check System
Version or model Dual-Spore
Company OSHA REVIEW INC
DUNS number 944030360
Product code FRC
GMDN term Biological sterilization indicator
Premarket submission K905425
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Mar 2, 2020
Version date Mar 10, 2020
Description Biological Indicator

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 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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