AccessGUDID - DEVICE: DYSIS v3 Digital Colposcope (05060477110010)

GUDID

Device Identifier (DI) Information

Brand Name: DYSIS v3 Digital Colposcope
Version or Model: DYS302 - DYSIS v3 ARM Assembly
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DYSIS MEDICAL LIMITED

Primary DI Number: 05060477110010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 424589138 *Terms of Use

Device Description: DYSIS with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. The PCI feature is an adjunctive tool for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. The system consists of 3 components; BASE Assembly, ARM Assembly and Monitor.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
10960	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HEX	Colposcope (And Colpomicroscope)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092433	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f54d6e15-80a2-4e6a-a4ba-82271e7bbd30
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 12, 2016