UDI device identifier

"U-test BI LR Biological Indicator LR" 81153

UDI device identifier 00060705811530 · MAXILL, INC.

Key facts

Primary DI 00060705811530
Brand name "U-test BI LR Biological Indicator LR"
Version or model 81153
Company MAXILL, INC.
DUNS number 079343581
Product code FRC
GMDN term Biological sterilization indicator
Premarket submission K111515
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Oct 19, 2016
Version date Jun 26, 2023

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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