UDI device identifier

Icy Hot SmartRelief SmartRelief 1.0 - Knee/Shoulder Kit

UDI device identifier 00041167080474 · CHATTEM, INC.

Key facts

Primary DI 00041167080474
Brand name Icy Hot SmartRelief
Version or model SmartRelief 1.0 - Knee/Shoulder Kit
Company CHATTEM, INC.
DUNS number 003336013
Product code NYN
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 Aug 25, 2016
Version date Feb 19, 2021
Description Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee and Shoulder

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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