DYSIS v3 Digital Colposcope

GUDID 15060477110017

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 ID15060477110017
NIH Device Record Keyf54d6e15-80a2-4e6a-a4ba-82271e7bbd30
Commercial Distribution StatusIn Commercial Distribution
Brand NameDYSIS v3 Digital Colposcope
Version Model NumberDYS302 - DYSIS v3 ARM Assembly
Company DUNS424589138
Company NameDYSIS MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060477110010 [Primary]
GS115060477110017 [Package]
Contains: 05060477110010
Package: BOX [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HEXColposcope (And Colpomicroscope)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

On-Brand Devices [DYSIS v3 Digital Colposcope]

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

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