UDI device identifier

Omron TENS Gel Refill PMGELCAN

UDI device identifier 00073796752316 · Omron Healthcare, Inc.

Key facts

Primary DI 00073796752316
Brand name Omron TENS Gel Refill
Version or model PMGELCAN
Catalog number PMGELCAN
Company Omron Healthcare, Inc.
DUNS number 054318779
Product code NYN
GMDN term Transcutaneous electrical stimulation electrode, single-use
Premarket submission K181992
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Jan 8, 2020
Version date Feb 19, 2021
Description Omron TENS Gel Refills are to be used with the OMRON TENS devices with heat.

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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