UDI device identifier

7LS FA7-1450J

UDI device identifier 00031262096265 · FKA DISTRIBUTING CO., LLC

Key facts

Primary DI 00031262096265
Brand name 7LS
Version or model FA7-1450J
Catalog number FA7-1450J
Company FKA DISTRIBUTING CO., LLC
DUNS number 183280973
Product code OHS
GMDN term Red/blue light phototherapy unit
Premarket submission K162098
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Feb 29, 2020
Version date Mar 9, 2020
Description ReNew Light Therapy

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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