ADVANCED LIMB RECONSTRUCTION SYSTEM 53555R

GUDID 18033509855870

ADV RADIOLUCENT LRS RAIL 350MM

ORTHOFIX SRL

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID18033509855870
NIH Device Record Keyb4dcabce-3c1c-46d4-9cb5-c10cd7b1b756
Commercial Distribution StatusIn Commercial Distribution
Brand NameADVANCED LIMB RECONSTRUCTION SYSTEM
Version Model Number1
Catalog Number53555R
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

Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter
Length350 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118033509855870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


[18033509855870]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-05

On-Brand Devices [ADVANCED LIMB RECONSTRUCTION SYSTEM ]

18054242510215ADV SMALL STRAIGHT CLAMP
18033509859199ALLEN HEAD BOLT FOR LRS ADV SYSTEM (PACK OF 25)
18033509858260ADULT LRS ADV HINGE CONNECTION
18033509858154KNEE HINGE CENTERING TEMPLATE
18033509858147CLAMP LOCKING SCREW (PACK OF 5 OF EACH)
18033509858123ADV RADIOLUCENT LRS RAIL 600 MM
18033509858116ADV RADIOLUCENT LRS RAIL 500 MM
18033509858109CLAMP LOCKING SCREW
18033509858086CLAMP SCREW (PACK OF 5 OF EACH)
18033509858079KNEE HINGE REPLACEMENT KIT
18033509856594ADV LRS SANDWICH CLAMP, HEIGHT: 8 MM
18033509856587ADV LRS SANDWICH CLAMP, HEIGHT: 15 MM
18033509856181ADV LRS RAIL 500MM
18033509856020ADV ACUTE DEROTATION ARC 100 MM
18033509855986ADV LRS INSTRUMENTS STERI-BOX EMPTY
18033509855887ADV RADIOLUCENT LRS RAIL 400MM
18033509855870ADV RADIOLUCENT LRS RAIL 350MM
18033509855863ADV RADIOLUCENT LRS RAIL 300MM
18033509855856ADV RADIOLUCENT LRS RAIL 250MM
18033509855849ADV RADIOLUCENT LRS RAIL 200MM
18033509855832ADV RADIOLUCENT LRS RAIL 120MM
18033509855825ADV RADIOLUCENT LRS KIT 200MM
18033509855818ADV RADIOLUCENT LRS KIT 400MM
18033509855801ADV RADIOLUCENT LRS KIT 300MM
18033509855795ADV LRS COMPONENTS STERI-BOX EMPTY B
18033509855788ADV LRS COMPONENTS STERI-BOX EMPTY A
18033509855771KNEE HINGE
18033509855764ADV MULTIPLANAR CLAMP
18033509855757ADV LRS RAIL 350MM
18033509855740ADV BALL-JOINT COUPLING
18033509855733ADV DYNA-RING
18033509855726ADV LRS KIT 200MM
18033509855719ADV LRS KIT 400MM
18033509855702ADV LRS KIT 300MM
18033509855696ADV MICROMETRIC SWIVELLING CLAMP
18033509855689ADV TRUELOK KIT FOR RING CONNECTION
18033509855672ADV GARCHES CD UNIT LONG EXTENDS 10CM
18033509855665ADV GARCHES CD UNIT STANDARD EXTENDS 5,5 CM
18033509855658ADV ACUTE CORRECTION T-TEMPLATE
18033509855641ADV ACUTE CORRECTION STRAIGHT TEMPLATE
18033509855634ADV ACUTE CORRECTION GARCHES TEMPLATE
18033509855627ADV ACUTE DEROTATION TEMPLATE
18032568039955ADV LRS RAIL 120MM
18032568039948ADV LRS RAIL 200MM
18032568039931ADV LRS RAIL 250MM
18032568039924ADV LRS RAIL 300MM
18032568039917ADV LRS RAIL 400MM
18032568039900ADV STRAIGHT CLAMP
18032568039894ADV MICROMETRIC TRANSLATION-ANGULATION CLAMP
18032568039887ADV T GARCHES CLAMP

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