NEXY

GUDID B667NEXY01

Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.

NEXT SIGHT SRL

Ophthalmic fundus camera Ophthalmic fundus camera

• Primary Device ID: B667NEXY01
• NIH Device Record Key: 3fc8b5d5-a762-449b-9440-862ae118dd73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEXY
• Version Model Number: 01
• Company DUNS: 437331574
• Company Name: NEXT SIGHT SRL
• 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: false
• 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
HIBCC	B667NEXY01 [Package]; Contains: B667NEXY1; Package: [1 Units]; In Commercial Distribution
HIBCC	B667NEXY1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180306

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: 2
• Public Version Date: 2019-12-16
• Device Publish Date: 2018-06-18

Devices Manufactured by NEXT SIGHT SRL

• B667PROTOZ01 - PROTOZ: 2019-12-17 ProtoZ is the Nexy device (an automatic eye-fundus camera intended for taking digital images of a human retina without the use o
• B667NEXY01 - NEXY: 2019-12-16Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent.
• B667NEXY01 - NEXY: 2019-12-16 Nexy device is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriati