DYSIS v3 Digital Colposcope

GUDID 15060477110000

DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnificati

DYSIS MEDICAL LIMITED

Colposcope

• Primary Device ID: 15060477110000
• NIH Device Record Key: 5c1fa2f9-06f0-4fca-a5f6-d9dd7bfd4856
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYSIS v3 Digital Colposcope
• Version Model Number: DYS302 - DYSIS v3 BASE Assembly
• Company DUNS: 424589138
• Company Name: DYSIS MEDICAL LIMITED
• 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: 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	05060477110003 [Primary]
GS1	15060477110000 [Package]; Contains: 05060477110003; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092433

FDA Product Code

• HEX: Colposcope (And Colpomicroscope)

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: 2018-07-06
• Device Publish Date: 2016-09-12

On-Brand Devices [DYSIS v3 Digital Colposcope]

• 15060477110017: DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and
• 15060477110000: DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and