LIGHTSonic B UBM

GUDID 00853386006285

LIGHTMED USA INC

Ophthalmic ultrasound imaging system
Primary Device ID00853386006285
NIH Device Record Key43dc2d6e-da77-4960-9558-e6ac0db83163
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIGHTSonic B UBM
Version Model NumberUS0000
Company DUNS162060383
Company NameLIGHTMED USA 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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853386006285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-01

Devices Manufactured by LIGHTMED USA INC

00853386006735 - Cyclophotocoagulation Probe2023-07-06
00853386006285 - LIGHTSonic B UBM2018-07-06
00853386006285 - LIGHTSonic B UBM2018-07-06

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