FDA-Device2014-11-26Class II
AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.
Soma Access Systems LLC
Hazard
There is a possibility the sterile packaging may fail before the expiration date specified on the package.
Sold states
Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CT, FL, GA, IN, KY, LA, MA, MI, MO, NC, NJ, NY OH, OR, PA, SC, TN, TX, VA, and WA and the countries of Belgium, Hong Kong, India, Japan, Panama and Singapore.
Affected count
3530 units
Manufactured in
109 Laurens Rd Ste 4c, N/A, Greenville, SC, United States
Products
AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0215-2015Don't want to check this manually?
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