NON-MYDRIATIC RETINAL CAMERA TRC-NW400

GUDID 04571130283022

TOPCON CORPORATION

Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera 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