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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Xiros8315 (DV) - 10050 SIC Graft; Xiros8315 (DV) - 102-1005 Poly-Tape 5 mm x 500 mm; 102-1080 Poly-Tape 10 mm x 800 mm; 102-1081 Poly-Tape 15 mm x 800 mm;; Xiros8315 (DV) - 102-1083 Poly-Tape 30 mm x 800 mm; 102-1143 AchilloCordPLUS; Xiros8315 (DV) - 102-1101 Infinity-Lock 5 mm x 400 mm; 102-1102 Infinity-Lock 7 mm x 400 mm; Xiros8315 (DV) -102-1082 Poly-Tape 20 mm x 800 mm; 102-1086 Poly-Tape 5 mm x 800 mm; 102-1087 Poly-Tape 7 mm x 800 mm
Classification Name: MESH, SURGICAL, NON-RESORBABLE, ORTHOPEDICS, REINFORCEMENT OF LIGAMENT
Product Code: QUW
Device Class: 2
Regulation Number: 878.3300
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: SYNERGY HEALTH STERILISATION UK LTD
Registered Establishment Number: 3002807315
Premarket Submission Number: K222978
Owner/Operator: STERIS Corporation
Owner/Operator Number: 10042227
Establishment Operations: Contract Sterilizer
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