Clarity ZMED-2XYAC-019

GUDID 00869958000124

The Clarity System delivers significant capabilities to improve the contrast, color, saturation and sharpness of surgical video.

Z MICROSYSTEMS, INC.

Endoscopic video image processing unit

• Primary Device ID: 00869958000124
• NIH Device Record Key: d1802849-209d-4247-84a6-fdc62a163c3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarity
• Version Model Number: ZMED-2XYAC-019
• Catalog Number: ZMED-2XYAC-019
• Company DUNS: 153647979
• Company Name: Z MICROSYSTEMS, 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: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 8588317064
• Email: rick.elliott@zmicro.com
• Phone: 8588317064
• Email: rick.elliott@zmicro.com
• Phone: 8588317064
• Email: rick.elliott@zmicro.com
• Phone: 8588317064
• Email: rick.elliott@zmicro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869958000117 [Primary]
GS1	00869958000124 [Package]; Contains: 00869958000117; Package: case of each [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130929

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-08