FDA-Device2020-05-13Class II
Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions
Gentell, Inc
Hazard
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Sold states
Worldwide distribution - US Nationwide distributions and the country of South Africa.
Affected count
22,439
Manufactured in
2701 Bartram Rd, N/A, Bristol, PA, United States
Products
Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1908-2020Don't want to check this manually?
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