FDA-Device2012-12-26Class II
Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy.
Varian Medical Systems, Inc.
Hazard
The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
Sold states
Worldwide Distribution - U.S. state of Georgia and the countries of Canada, Germany, India, Poland, and Thailand.
Affected count
15 units
Manufactured in
700 Harris St Ste 109, Charlottesville, VA, United States
Products
Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0607-2013Don't want to check this manually?
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