APEX LED

GUDID 00850053798016

LIGHT HEAD APEX LED, BURTON

Burton Medical, LLC

Operating room light system
Primary Device ID00850053798016
NIH Device Record Keyf3d24d6b-472a-40fd-b1be-04e933741b82
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPEX LED
Version Model NumberAPLED
Company DUNS081056859
Company NameBurton Medical, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850053798016 [Primary]

FDA Product Code

FSYLight, Surgical, Ceiling Mounted

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-27
Device Publish Date2026-02-19

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