DYSIS Ultra

GUDID 15060477110062

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: 15060477110062
• NIH Device Record Key: 8418f2dc-f04f-40d3-b655-e461800b47f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYSIS Ultra
• Version Model Number: DYS402 - DYSIS Ultra
• 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	05060477110065 [Primary]
GS1	15060477110062 [Package]; Contains: 05060477110065; 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: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-25

Devices Manufactured by DYSIS MEDICAL LIMITED

• 05060477110263 - DYSIS View: 2023-12-11 DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumi
• 15060477110185 - DYSIS Ultra 2.0: 2019-03-11 DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumi
• 15060477110000 - DYSIS v3 Digital Colposcope: 2018-07-06 DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumi
• 15060477110017 - DYSIS v3 Digital Colposcope: 2018-07-06 DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumi
• 05060477110027 - DYSIS v3 Digital Coploscope: 2018-07-06 DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumi
• 15060477110062 - DYSIS Ultra: 2018-07-06DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnificati
• 15060477110062 - DYSIS Ultra: 2018-07-06 DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumi