PREFIX FIXATOR 92125

GUDID 18032568866155

ROD 125 MM LONG

ORTHOFIX SRL

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID18032568866155
NIH Device Record Key279a5c96-97cd-42c0-a3e2-6b6a63bf3464
Commercial Distribution StatusIn Commercial Distribution
Brand NamePREFIX FIXATOR
Version Model Number1
Catalog Number92125
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

Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter
Width8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118032568866155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


[18032568866155]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-08

On-Brand Devices [PREFIX FIXATOR]

18054242511403JP PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS
18033509856518COMPLETE PREFIX II KIT
18033509856174US PREFIX II ANKLE COMPLETE KIT STERILE
18033509856167US PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS
18033509856150US PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS
18033509856143US PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS
18033509855979PREFIX II ANKLE COMPLETE KIT STERILE
18033509855962PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS
18033509855955PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS
18033509855948PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS
18033509851780TRANSFIXING PIN, THREAD L 80 MM STERILE SHAFT D 4MM, THREAD D 5MM
18033509851773TRANSFIXING PIN, THREAD L 50 MM STERILE SHAFT D 4MM, THREAD D 5MM
18032937168873ROD 900 MM LONG
18032937168866ROD 800 MM LONG
18032568869286PIN GUIDE
18032568869279MULTI SCREW CLAMP GUIDE
18032568869262MULTI SCREW CLAMP
18032568868678ROD 500 MM LONG
18032568868661ROD 400 MM LONG
18032568867503TRANSFIXING PIN, THREAD L 50 MM SHAFT D 4MM, THREAD D 5MM
18032568867480TRANSFIXING PIN CLAMP
18032568867305PREFIX STERIBOX, EMPTY
18032568867237SCREW CLIP CLAMP
18032568867220ROD CLIP CLAMP
18032568866568ROD 600 MM LONG
18032568866186ROD 350 MM LONG
18032568866179ROD 275 MM LONG
18032568866162ROD 175 MM LONG
18032568866155ROD 125 MM LONG
18053504369899Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.

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