UDI device identifier

Icy Hot SmartRelief SmartRelief 1.0 - Club Pack

UDI device identifier 00041167080818 · CHATTEM, INC.

Key facts

Primary DI 00041167080818
Brand name Icy Hot SmartRelief
Version or model SmartRelief 1.0 - Club Pack
Company CHATTEM, INC.
DUNS number 003336013
Product code NUH
GMDN term Transcutaneous electrical stimulation electrode, single-use
Premarket submission K131159
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Sep 15, 2016
Version date Feb 19, 2021
Description Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Club Pack size - Back & Hip

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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