UDI device identifier

TrueStim HD-08B(TSG-E1)

UDI device identifier 00081009308007 · Hi-Dow International Incorporated

Key facts

Primary DI 00081009308007
Brand name TrueStim
Version or model HD-08B(TSG-E1)
Company Hi-Dow International Incorporated
DUNS number 124034476
Product code ILX
GMDN term Short-wave diathermy treatment system, home-use
Premarket submission K202337
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Sep 28, 2023
Version date Oct 6, 2023
Description Pulsed Electromagnetic Field Wrap, Black, lower limb wrap

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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