FDA.report

Virtual Field

Primary DI
00860001720402
Brand
Virtual Field
Company
Virtual Field, Inc.
Model
VF3 Pro
Device description
VF3 Pro is a portable virtual reality visual field device. It runs a variety of visual field patterns, including but not limited to 10-2, 24-2, and 30-2, as well as multiple strategies, from suprathreshold screenings to full threshold tests. It also includes eye tracking capabilities, a color vision screening exam, and a pupillometer exam.
Published
2023-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HPTPerimeter, Automatic, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
HPTPerimeter, Automatic, Ac-PoweredOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860001720402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001720402008600017204028600017204020860001720402

GMDN Terms

TermDefinition
Pupil-size/-light reflex meterAn electrically-powered, hand-held instrument intended to objectively measure the size of the eye’s pupil and the pupil’s reactivity to light, typically as part of an ophthalmic or neurological procedure. Also known as a pupilometer, it is a hand-held device with controls and display intended to show the measurements.

Sterilization Methods

Method

Contacts

PhoneEmail
(858) 208-0074support@virtualfield.io

Regulatory Flags

DUNS number
099254165
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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