UDI device identifier

u-test Self-Contained Biological Indicator for Steam Sterilization (SCBI) 81154

UDI device identifier 00060705811547 · MAXILL, INC.

Key facts

Primary DI 00060705811547
Brand name u-test Self-Contained Biological Indicator for Steam Sterilization (SCBI)
Version or model 81154
Company MAXILL, INC.
DUNS number 079343581
Product code FRC
GMDN term Biological sterilization indicator
Premarket submission K163144
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Aug 17, 2017
Version date Jul 6, 2018

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:

Browse all UDI device identifiers (GUDID)