Home GUDID 15060477110062 DYSIS Ultra
Primary DI 15060477110062
Brand DYSIS Ultra
Company DYSIS MEDICAL LIMITED
Model DYS402 - DYSIS Ultra
Device description DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnificati
Published 2018-03-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HEX Colposcope (And Colpomicroscope)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HEX Colposcope (And Colpomicroscope) Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 15060477110062 Package GS1 1 In Commercial Distribution 05060477110065 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 15060477110062 15060477110062 05060477110065 05060477110065 5060477110065
GMDN Terms# Term, Definition table Term Definition Colposcope An electrically-powered instrument intended to be used for the visual examination and treatment of the female genitalia. It is placed directly at the opening of the vagina which is held open with an inserted speculum during colposcopy. The instrument has a light source and magnifying lenses that allow the physician to view the interior of the vagina, particularly the uterine cervix. This device is used to check for cervical cancer typically after an abnormal Papanicolaou test (PAP) or as a follow up procedure to view an abnormal area seen during an earlier gynaecological examination. During colposcopy, samples of tissue can be taken from the cervix for testing.
Regulatory Flags# DUNS number 424589138 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05060477110263 DYSIS View VIE001 VIE001 2023-12-01 05060477110188 DYSIS Ultra 2.0 DYS403 2019-02-22 15060477110185 DYSIS Ultra 2.0 DYS403 2019-02-22 05060477110003 DYSIS v3 Digital Colposcope DYS302 - DYSIS v3 BASE Assembly 2016-09-12 05060477110010 DYSIS v3 Digital Colposcope DYS302 - DYSIS v3 ARM Assembly 2016-09-12 05060477110065 DYSIS Ultra DYS402 - DYSIS Ultra 2018-03-25 15060477110000 DYSIS v3 Digital Colposcope DYS302 - DYSIS v3 BASE Assembly 2016-09-12 15060477110017 DYSIS v3 Digital Colposcope DYS302 - DYSIS v3 ARM Assembly 2016-09-12 05060477110027 DYSIS v3 Digital Coploscope "MON001 - DYSIS v3 19"" Monitor Assembly" 2016-09-12
Other Devices Sharing Product Codes#