SightSaverMini

GUDID 00860003291009

ANSCHEL TECHNOLOGY INC.

Visual stimulator
Primary Device ID00860003291009
NIH Device Record Key862d8be0-d4ce-4795-8527-49aad8d87796
Commercial Distribution StatusIn Commercial Distribution
Brand NameSightSaverMini
Version Model NumberATMV001
Company DUNS966842036
Company NameANSCHEL TECHNOLOGY 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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS100860003291009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWEStimulator, Photic, Evoked Response

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-01
Device Publish Date2024-01-24

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