Profile: Taiwan Advanced Sterilization Technology Inc. is engaged in the production of X-ray detectable gauze.
FDA Registration Number: 3007127244
US Agent: Pragmatic Compliance Llc / Pragmatic Compliance Llc
Phone: +1-(716)-775-0533 E-Mail:
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• X-Ray Detectable Gauze (FDA Code: GDY / 878.4450) Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements. |