CLARUS

GUDID 04057748096044

The CLARUS 700 is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye.The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and the choroid.

Carl Zeiss Meditec, Inc.

Ophthalmic fundus camera

• Primary Device ID: 04057748096044
• NIH Device Record Key: d209ceb8-77d1-4c9f-9043-c84e50e26289
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLARUS
• Version Model Number: 700
• Company DUNS: 362747011
• Company Name: Carl Zeiss Meditec, Inc.
• 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: false
• 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
GS1	04057748096044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191194

FDA Product Code

• QER: Camera, Ophthalmic, Slit-Scanning

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: 2019-07-09
• Device Publish Date: 2019-07-01

On-Brand Devices [CLARUS]

• 04057748096051: The CLARUS is an active, non-contact, software controlled, high resolution imaging device for in
• 04057748096037: The CLARUS 500 is an active, non-contact, software controlled, high resolution imaging device fo
• 04057748096044: The CLARUS 700 is an active, non-contact, software controlled, high resolution imaging device fo