NON-MYDRIATIC RETINAL CAMERA TRC-NW400

GUDID 04571130283022

TOPCON CORPORATION

Ophthalmic fundus camera

• Primary Device ID: 04571130283022
• NIH Device Record Key: f3b5822e-33d2-42f8-903f-1e7a5c4889d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NON-MYDRIATIC RETINAL CAMERA TRC-NW400
• Version Model Number: TRC-NW400
• Company DUNS: 690542881
• Company Name: TOPCON CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	04571130283022 [Primary]

FDA Product Code

• HKI: Camera, ophthalmic, ac-powered

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: 2022-02-07
• Device Publish Date: 2022-01-28

On-Brand Devices [NON-MYDRIATIC RETINAL CAMERA TRC-NW400]

• 04562123287325: TRC-NW400
• 04571130283022: TRC-NW400