FDA-Device2019-05-22Class II
Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Shippert Medical Technologies
Hazard
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Sold states
Distribution was nationwide, including PR. There was government/military distribution. Foreign distribution was made to Australia, Austria, Belgium, Denmark, Germany, Greece, India, Italy, Japan, Netherlands, New Zealand, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom,
Affected count
6,553 units were distributed for all catalog numbers
Manufactured in
6248 S Troy Cir Ste A, Centennial, CO, United States
Products
Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1331-2019Don't want to check this manually?
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