FDA.reportPublic FDA data

SightSaverMini

Primary DI
00860003291009
Brand
SightSaverMini
Company
ANSCHEL TECHNOLOGY INC.
Model
ATMV001
Published
2024-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GWEStimulator, Photic, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113785000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113785000ADHERENT VISUAL STIMULATOR GOGGLESAnschel Technology, Inc.2012-06-06GWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003291009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003291009008600032910098600032910090860003291009

GMDN Terms#

Term, Definition table
TermDefinition
Visual stimulatorAn electronic device used to apply visual stimuli (e.g., shifting patterns of light) to a patient's eyes. This device typically presents light to the eye through an optical system (optical stimulator), or light is viewed directly from an illuminated screen (direct-view stimulator), or light-emitting diode (LED) stimulating goggles. It is typically used as a component of several other devices such as refractors, scanning ophthalmoscopes, visual evoked potential (VEP) recording systems, or an electroretinograph (ERG).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966842036
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857901006620RETeval™L K C TECHNOLOGIES, INC.GWE2025-07-01
00857901006637RETeval™L K C TECHNOLOGIES, INC.GWE2025-07-01
08056446900338NeMus 2 600EB NEURO SPAGWE2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWE2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWE2025-05-26
08056446901038GOGGLES STIMULATOR IIEB NEURO SPAGWE2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWE2025-05-22
08056446901113NExT-PADEB NEURO SPAGWE2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWE2025-05-22
08056446901137NExT-HSEB NEURO SPAGWE2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWE2025-05-22
08056446901199NExT-ASEB NEURO SPAGWE2025-05-22
08056446901205NExT StationEB NEURO SPAGWE2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWE2025-05-19
08056446900185USB FLASH ADAPTER CABLE L=3mEB NEURO SPAGWE2024-12-04
08056446900192USB FLASH ADAPTER CABLE L=5mEB NEURO SPAGWE2024-12-04
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103982Sierra SummitCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.GWE2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-06-21
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102909Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102916Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04