CLARUS

GUDID 04057748096037

The CLARUS 500 is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye. The CLARUS 500 oph

Carl Zeiss Meditec, Inc.

Ophthalmic fundus camera

• Primary Device ID: 04057748096037
• NIH Device Record Key: f488dec3-78a0-4295-86fc-4ada98cb84e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLARUS
• Version Model Number: 500
• 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	04057748096037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181444

FDA Product Code

• QER: Camera, Ophthalmic, Slit-Scanning

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: 2019-03-08
• Device Publish Date: 2017-09-25

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