FloNavi Light Source

GUDID 06973031299962

Guangdong Optomedic Technologies, Inc.

Stationary general-purpose fluoroscopic x-ray system, digital
Primary Device ID06973031299962
NIH Device Record Key8cc34fb0-55a0-4663-97d8-d360c19f8389
Commercial Distribution StatusIn Commercial Distribution
Brand NameFloNavi Light Source
Version Model NumberOPTO-LED2100
Company DUNS544527790
Company NameGuangdong Optomedic Technologies, 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 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
GS106973031299962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-02
Device Publish Date2024-03-25

On-Brand Devices [FloNavi Light Source]

06973031299672Light Source
06973031299962OPTO-LED2100

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