G-Beam Fusion Beaming System 99-875125

GUDID 18053504360612

G-BEAM STAINLESS STEEL FUSION BEAM L125MM D5.4MM STERILE

ORTHOFIX SRL

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 18053504360612
• NIH Device Record Key: c27dc5c5-fb68-414f-ae46-d4166a5a740a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-Beam Fusion Beaming System
• Version Model Number: 1
• Catalog Number: 99-875125
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +0390456719000
• Email: info@orthofix.it
• Phone: +0390456719000
• Email: info@orthofix.it

Device Dimensions

• Outer Diameter: 5.4 Millimeter
• Length: 125 Millimeter
• Outer Diameter: 5.4 Millimeter
• Length: 125 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053504360612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172698

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-23

On-Brand Devices [G-Beam Fusion Beaming System]

• 18053504360896: G-BEAM KIT COMPLETE
• 18053504360872: G-BEAM STERILIZATION TRAY COMPLETE
• 18053504360865: G-BEAM STERILIZATION TRAY
• 18053504360858: CONICAL THREADED EXTRACTOR
• 18053504360841: RATCHETING T-HANDLE
• 18053504360834: WIRE GUIDE
• 18053504360827: SMALL EXTRACTION TOOL D5.4MM
• 18053504360810: LARGE EXTRACTION TOOL D7.4MM
• 18053504360803: LARGE HEX SCREWDRIVER 5MM
• 18053504360797: SMALL HEX SCREWDRIVER 4MM
• 18053504360780: DRILL GUIDE
• 18053504360773: LARGE GUIDEWIRE D2.8MM STERILE
• 18053504360766: SMALL GUIDEWIRE D1.9MM STERILE
• 18053504360759: SIZING GAUGE
• 18053504360742: LARGE STEPPED DRILL D5.1-7.5MM
• 18053504360735: SMALL STEPPED DRILL D4-5.5MM
• 18053504360728: G-BEAM STAINLESS STEEL END CAP HIGH COMPRESSION STERILE
• 18053504360711: G-BEAM STAINLESS STEEL END CAP LOW COMPRESSION STERILE
• 18053504360704: G-BEAM STAINLESS STEEL FUSION BEAM L170MM D5.4MM STERILE
• 18053504360698: G-BEAM STAINLESS STEEL FUSION BEAM L165MM D5.4MM STERILE
• 18053504360681: G-BEAM STAINLESS STEEL FUSION BEAM L160MM D5.4MM STERILE
• 18053504360674: G-BEAM STAINLESS STEEL FUSION BEAM L155MM D5.4MM STERILE
• 18053504360667: G-BEAM STAINLESS STEEL FUSION BEAM L150MM D5.4MM STERILE
• 18053504360650: G-BEAM STAINLESS STEEL FUSION BEAM L145MM D5.4MM STERILE
• 18053504360643: G-BEAM STAINLESS STEEL FUSION BEAM L140MM D5.4MM STERILE
• 18053504360636: G-BEAM STAINLESS STEEL FUSION BEAM L135MM D5.4MM STERILE
• 18053504360629: G-BEAM STAINLESS STEEL FUSION BEAM L130MM D5.4MM STERILE
• 18053504360612: G-BEAM STAINLESS STEEL FUSION BEAM L125MM D5.4MM STERILE
• 18053504360605: G-BEAM STAINLESS STEEL FUSION BEAM L120MM D5.4MM STERILE
• 18053504360599: G-BEAM STAINLESS STEEL FUSION BEAM L115MM D5.4MM STERILE
• 18053504360582: G-BEAM STAINLESS STEEL FUSION BEAM L110MM D5.4MM STERILE
• 18053504360575: G-BEAM STAINLESS STEEL FUSION BEAM L105MM D5.4MM STERILE
• 18053504360568: G-BEAM STAINLESS STEEL FUSION BEAM L100MM D5.4MM STERILE
• 18053504360551: G-BEAM STAINLESS STEEL FUSION BEAM L95MM D5.4MM STERILE
• 18053504360544: G-BEAM STAINLESS STEEL FUSION BEAM L90MM D5.4MM STERILE
• 18053504360537: G-BEAM STAINLESS STEEL FUSION BEAM L85MM D5.4MM STERILE
• 18053504360520: G-BEAM STAINLESS STEEL FUSION BEAM L80MM D5.4MM STERILE
• 18053504360513: G-BEAM STAINLESS STEEL FUSION BEAM L75MM D5.4MM STERILE
• 18053504360506: G-BEAM STAINLESS STEEL FUSION BEAM L70MM D5.4MM STERILE
• 18053504360490: G-BEAM STAINLESS STEEL FUSION BEAM L65MM D5.4MM STERILE
• 18053504360483: G-BEAM STAINLESS STEEL FUSION BEAM L60MM D.4MM STERILE
• 18053504360476: G-BEAM STAINLESS STEEL FUSION BEAM L55MM D5.4MM STERILE
• 18053504360469: G-BEAM STAINLESS STEEL FUSION BEAM L50MM D5.4MM STERILE
• 18053504360452: G-BEAM STAINLESS STEEL FUSION BEAM L200MM D7.4MM STERILE
• 18053504360445: G-BEAM STAINLESS STEEL FUSION BEAM L195MM D7.4MM STERILE
• 18053504360438: G-BEAM STAINLESS STEEL FUSION BEAM L190MM D7.4MM STERILE
• 18053504360421: G-BEAM STAINLESS STEEL FUSION BEAM L185MM D7.4MM STERILE
• 18053504360414: G-BEAM STAINLESS STEEL FUSION BEAM L180MM D7.4MM STERILE
• 18053504360407: G-BEAM STAINLESS STEEL FUSION BEAM L175MM D7.4MM STERILE
• 18053504360391: G-BEAM STAINLESS STEEL FUSION BEAM L170MM D7.4MM STERILE