Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Laparoscope, General & Plastic Surgery (GCJ) (1) Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (NBY) (1) System,Surgical,Computer Controlled Instrument (NAY) (1)