G-Beam Fusion Beaming System 99-877100

GUDID 18053504360254

G-BEAM STAINLESS STEEL FUSION BEAM L100MM D7.4MM STERILE

ORTHOFIX SRL

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID18053504360254
NIH Device Record Key6f555ec4-954e-4520-8d40-861a0b1dba10
Commercial Distribution StatusIn Commercial Distribution
Brand NameG-Beam Fusion Beaming System
Version Model Number1
Catalog Number99-877100
Company DUNS438793622
Company NameORTHOFIX SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it

Device Dimensions

Outer Diameter7.4 Millimeter
Length100 Millimeter
Outer Diameter7.4 Millimeter
Length100 Millimeter
Outer Diameter7.4 Millimeter
Length100 Millimeter
Outer Diameter7.4 Millimeter
Length100 Millimeter
Outer Diameter7.4 Millimeter
Length100 Millimeter
Outer Diameter7.4 Millimeter
Length100 Millimeter
Outer Diameter7.4 Millimeter
Length100 Millimeter
Outer Diameter7.4 Millimeter
Length100 Millimeter
Outer Diameter7.4 Millimeter
Length100 Millimeter
Outer Diameter7.4 Millimeter
Length100 Millimeter
Outer Diameter7.4 Millimeter
Length100 Millimeter
Outer Diameter7.4 Millimeter
Length100 Millimeter
Outer Diameter7.4 Millimeter
Length100 Millimeter
Outer Diameter7.4 Millimeter
Length100 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118053504360254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-23

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

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