FDA-Device2021-06-09Class II
Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
CLINICAL LASERTHERMIA SYSTEMS AB
Hazard
single use devices labeled as sterile may not have been adequately sterilized
Sold states
Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.
Affected count
40 units
Manufactured in
Scheelevagen 2, Lund, Sweden
Products
Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1781-2021Don't want to check this manually?
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