FDA-Device2023-10-25Class II
Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)
North Coast Medical Inc
Hazard
The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.
Sold states
US: NC, CA, WI OUS: New Zealand, Australia,
Affected count
27 units
Manufactured in
135 E Main Ave Ste 110, N/A, Morgan Hill, CA, United States
Products
Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0125-2024Don't want to check this manually?
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