GALAXY FIXATION SYSTEM 939250

GUDID 18033509859410

ROD D 9 MM L 250 MM

ORTHOFIX SRL

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID18033509859410
NIH Device Record Key188b7cf6-b5e3-4430-8278-1ac6aaed0b42
Commercial Distribution StatusIn Commercial Distribution
Brand NameGALAXY FIXATION SYSTEM
Version Model Number1
Catalog Number939250
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 Datefalse
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
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it

Device Dimensions

Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter
Length250 Millimeter
Outer Diameter9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118033509859410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

[18033509859410]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-20

On-Brand Devices [GALAXY FIXATION SYSTEM]

18054242518969GALAXY TL-HEX CONNECTING POST L100MM D12MM STERILE
18054242518952GALAXY TL-HEX CONNECTING POST L100MM D 12MM
18054242518945GALAXY TL-HEX CONNECTING POST L50MM D12MM STERILE
18054242518938GALAXY TL-HEX CONNECTING POST L50MM D 12MM
18054242518716GALAXY MEDIUM - PAEDIATRIC STERILE KIT - SCREW THREAD D4MM
18054242518709GALAXY MEDIUM - PAEDIATRIC STERILE KIT - SCREW THREAD D5MM
18054242518693GALAXY FIXATION SYSTEM SEMICIRCULAR ROD D12MM L250MM LARGE STERILE
18054242518686GALAXY FIXATION SYSTEM SEMICIRCULAR ROD D12MM L215MM MEDIUM STERILE
18054242518679GALAXY FIXATION SYSTEM SEMICIRCULAR ROD D12MM L180MM SMALL STERILE
18054242515203GALAXY ANKLE BRIDGING DELTA FRAME STERILE KIT
18054242515197GALAXY SMALL SPANNING 'Z' FRAME STERILE KIT
18054242511670SMALL MULTISCREW CLAMP-SHORT STERILE
18054242511663SMALL MULTISCREW CLAMP-LONG STERILE
18054242511656Galaxy Wrist Sterile Kit
18054242511649SCREW GUIDE
18054242511632T-WRENCH 4MM SHAFT
180542425116256 MM L ROD
18054242511618WRIST MODULE
18054242511601SMALL MULTISCREW CLAMP-SHORT
18054242511595SMALL MULTISCREW CLAMP-LONG
18054242511588GALAXY WRIST TRAY EMPTY
18054242511540SHOULDER STERILE KIT
18054242511533ELBOW STERILE KIT
18054242511526MEDIUM MULTISCREW CLAMP STERILE
18054242511519LARGE-MEDIUM TRANSITION CLAMP STERILE
18054242511502SEMI CIRCULAR ROD D 9 MM LARGE
18054242511496SEMI CIRCULAR ROD D 9 MM MEDIUM
18054242511489SEMI CIRCULAR ROD D 9 MM SMALL
18054242511472MEDIUM MULTISCREW CLAMP
18054242511465LARGE-MEDIUM TRANSITION CLAMP
18054242511397TRANSFIX PIN 80 MM QC
18054242511380TRANSFIX PIN 50 MM QC
18054242511328GALAXY ELBOW EMPTY TRAY
18054242511311GALAXY INSTRUMENTS EMPTY TRAY
18054242511304ANKLE TRANSFIX PIN STERILE KIT
18054242511298TIBIA FEMUR DIAPHYSEAL STERILE KIT
18054242511281PELVIS STERILE KIT
18054242510895LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA)
18054242510888PELVIS STERILE KIT (STERILE GAMMA)
18054242510833KIT FISSATORE GALAXY PER SPALLA
18054242510147DISTRACTOR CAM
18054242510130GALAXY SHOULDER EMPTY TRAY
18054242510123GALAXY ELBOW EMPTY TRAY
18054242510116GALAXY LOWER EMPTY TRAY
18054242510109GALAXY UPPER EMPTY TRAY
18054242510093GALAXY UPPER+INSTRUMENTS EMPTY TRAY
18054242510086GALAXY LOWER+INSTRUMENTS EMPTY TRAY
18054242510079GALAXY INSTRUMENTS EMPTY TRAY
18054242510062GALAXY UPPER+LOWER EMPTY TRAY
18054242510055WIRE BENDER
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