FDA-Device2026-01-07Class II
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
Sheathing Technologies Inc
Hazard
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
Sold states
US Nationwide distribution in the state of WA.
Affected count
12
Manufactured in
675 Jarvis Dr, N/A, Morgan Hill, CA, United States
Products
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1006-2026Don't want to check this manually?
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