RHA

GUDID 00627843652021

The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to capture images of the fundus of the eye which can be used to assist in diagnosis and observation of fundus diseases.

Annidis Health Systems Corp

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• Primary Device ID: 00627843652021
• NIH Device Record Key: 27e6a7c9-f70d-4462-ac44-af63b1c40370
• Commercial Distribution Discontinuation: 2021-08-05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RHA
• Version Model Number: RHA2020/2020-U
• Company DUNS: 243651440
• Company Name: Annidis Health Systems Corp
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 613 596 1800
• Email: jeandc@annidis.com
• Phone: 613 596 1800
• Email: jeandc@annidis.com
• Phone: 613 596 1800
• Email: jeandc@annidis.com
• Phone: 613 596 1800
• Email: jeandc@annidis.com
• Phone: 613 596 1800
• Email: jeandc@annidis.com
• Phone: 613 596 1800
• Email: jeandc@annidis.com
• Phone: 613 596 1800
• Email: jeandc@annidis.com
• Phone: 613 596 1800
• Email: jeandc@annidis.com
• Phone: 613 596 1800
• Email: jeandc@annidis.com
• Phone: 613 596 1800
• Email: jeandc@annidis.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627843652021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111531

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-05