
Angiomed U.S., Inc.
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PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) is an FDA 510(k)-cleared medical device (K854907) manufactured by Angiomed U.S., Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 23, 1986. Regulation: 8.