Paxos Scope

GUDID 00851434007024

DigiSight Technologies Inc. Paxos Scope Ophthalmic Camera

DIGISIGHT TECHNOLOGIES, INC.

Ophthalmic fundus camera

• Primary Device ID: 00851434007024
• NIH Device Record Key: d6a1839b-6a1f-4b62-838a-786734c0ca60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paxos Scope
• Version Model Number: 41177
• Company DUNS: 090751433
• Company Name: DIGISIGHT TECHNOLOGIES, 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-650-223-5560
• Email: veronica.morales@digisight.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851434007024 [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: 2018-06-25
• Device Publish Date: 2018-05-25

On-Brand Devices [Paxos Scope]

• 00851434007024: DigiSight Technologies Inc. Paxos Scope Ophthalmic Camera
• 00851434007017: DigiSIght Technologies Inc. Paxos Scope Ophthalmic Camera with optional 20D acrylic lens
• 00851434007000: DigiSight Technologies Inc. Paxos Scope Ophthalmic Camera