FDA.reportPublic FDA data

WRI-1

Primary DI
00628678036055
Brand
WRI-1
Company
Cellview Imaging Inc.
Model
01
Device description
The device WRI-1 is an ophthalmic imaging device and intended to be used by health care professionals to capture, display, and store color and monochrome images of the retina without contact to the patient eye.
Published
2022-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
PJZCamera, Ophthalmic, General-Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJZCamera, Ophthalmic, General-UseOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628678036055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628678036055006286780360556286780360550628678036055

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fundus cameraAn electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203780184
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628678036017WRI-1012022-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010859193OptaseScope Health Inc.PJZ2026-05-01
00860014277559MarcoLombart Brothers, Inc.PJZ2026-03-02
06430046260993Optomed Lumo Camera setOptomed OyPJZ2025-11-13
00860012447121EyeCasterInnovations Lightx IncPJZ2025-11-12
00860012447138EyeCasterInnovations Lightx IncPJZ2025-11-12
00860012447145EyeCasterInnovations Lightx IncPJZ2025-11-12
06973211070619Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
06973211071500Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
06973211071517Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
00850067214229identifeye Camera System, tabletIdentifeye Health Inc.PJZ2025-07-07
00850067214236identifeye Camera System, power supplyIdentifeye Health Inc.PJZ2025-07-07
00850067214274identifeye Camera SystemIdentifeye Health Inc.PJZ2025-07-07
00850067214281identifeye Camera System, reconditionedIdentifeye Health Inc.PJZ2025-07-07
06976107790301AirdocChangsha Airdoc Health Technology Co., Ltd.PJZ2024-09-27
07908616100097Eyer 2 BasicPHELCOM TECHNOLOGIES SAPJZ2024-09-23
00860011978305EntireEye PortableRETIVUE, LLCPJZ2024-07-18
00811608014708Volk VivaVOLK OPTICAL INC.PJZ2024-04-05
00811608014739Volk VivaVOLK OPTICAL INC.PJZ2024-04-05
00860010826812Oivi Opthalmic Fundus CameraOivi ASPJZ2024-01-15
00853501008002Spect Ophthalmic CameraSpect Inc.PJZ2023-08-10
10860000249543Verily Retinal CameraVERILY LIFE SCIENCES LLCPJZ2023-05-24
07908616100042EyerPHELCOM TECHNOLOGIES SAPJZ2023-04-27
08056389701405ME-CHECK 4ESPANSIONE MARKETING SPAPJZ2023-04-05
00811608013770Volk VistaViewVOLK OPTICAL INC.PJZ2022-11-16
00850038195229Eli EzerU.S. OPHTHALMIC, L.L.C.PJZ2022-11-03
06945087500088MediworksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.PJZ2022-11-02
00628678036017WRI-1Cellview Imaging Inc.PJZ2022-09-08
06973211070008Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2022-06-08
08906096520052RemidioREMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITEDPJZ2022-01-31
18437014903024HD AnalyzerVISIOMETRICS SLPJZ2022-01-21