WRI-1

GUDID 00628678036055

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.

Cellview Imaging Inc.

Ophthalmic fundus camera

• Primary Device ID: 00628678036055
• NIH Device Record Key: 00d5dfa9-dd80-4840-83a8-6f9a7be117bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WRI-1
• Version Model Number: 01
• Company DUNS: 203780184
• Company Name: Cellview Imaging Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628678036055 [Primary]

FDA Product Code

• PJZ: Camera, Ophthalmic, General-Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-16
• Device Publish Date: 2022-09-08