CIRRUS HD-OCT

GUDID 04057748087097

The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional

Carl Zeiss Meditec, Inc.

Spectral-domain optical coherence tomography system

• Primary Device ID: 04057748087097
• NIH Device Record Key: 8ef6aead-9554-453b-aa47-0f69ea4d08f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CIRRUS HD-OCT
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04057748087097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150977

FDA Product Code

• OBO: Tomography, Optical Coherence

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: 2018-10-26
• Device Publish Date: 2016-08-25

On-Brand Devices [CIRRUS HD-OCT]

• 04057748087127: The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging de
• 04057748087097: The CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging de
• 04057748087080: The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining dev
• 04057748087141: The CIRRUS HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imagining dev