Vistor PR LED

GUDID 00816835020355

MI-750 Minor Surgical Light, Dual Ceiling

MEDICAL ILLUMINATION INTERNATIONAL INC.

Medical monitor/light mount
Primary Device ID00816835020355
NIH Device Record Keybcee12a4-359c-4bd7-af26-d25a6e721bef
Commercial Distribution StatusIn Commercial Distribution
Brand NameVistor PR LED
Version Model NumberNV061415
Company DUNS093357739
Company NameMEDICAL ILLUMINATION INTERNATIONAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
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
GS100816835020355 [Primary]
GS101816835020354 [Package]
Package: BOX [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FSYLight, Surgical, Ceiling Mounted

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-12
Device Publish Date2016-09-23

On-Brand Devices [Vistor PR LED]

00816835020553MI-750 Minor Surgical Light, Floor Stand with Battery Back-up
00816835020492MI-750 Minor Surgical Light, Dual Ceiling
00816835020485MI-750 Minor Surgical Light, Single Ceiling
00816835020478MI-750 Minor Surgical Light, Wall Mount
00816835020461MI-750 Minor Surgical Light, Floor Stand
00816835020416MI-750 Minor Surgical Light, Floor Stand with Battery Back-up
00816835020355MI-750 Minor Surgical Light, Dual Ceiling
00816835020348MI-750 Minor Surgical Light, Single Ceiling
00816835020331MI-750 Minor Surgical Light, Wall Mount
00816835020324MI-750 Minor Surgical Light, Floor Stand

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