PAEDIATRIC LIMB RECONSTRUCTION SYSTEM 55008

GUDID 18032568036657

PAEDIATRIC LRS C/D UNIT EXTENDS TO 6.2 CM

ORTHOFIX SRL

External orthopaedic fixation system, reusable
Primary Device ID18032568036657
NIH Device Record Key5ce5edcd-f86d-413f-a1be-5c17a8be4e52
Commercial Distribution StatusIn Commercial Distribution
Brand NamePAEDIATRIC LIMB RECONSTRUCTION SYSTEM
Version Model Number1
Catalog Number55008
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 Usefalse
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

Device Dimensions

Width5 Millimeter
Width5 Millimeter
Width5 Millimeter
Width5 Millimeter
Width5 Millimeter
Width5 Millimeter
Width5 Millimeter
Width5 Millimeter
Width5 Millimeter
Width5 Millimeter
Width5 Millimeter
Width5 Millimeter
Width5 Millimeter
Width5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118032568036657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18032568036657]

Moist Heat or Steam Sterilization

[18032568036657]

Moist Heat or Steam Sterilization

[18032568036657]

Moist Heat or Steam Sterilization

[18032568036657]

Moist Heat or Steam Sterilization

[18032568036657]

Moist Heat or Steam Sterilization

[18032568036657]

Moist Heat or Steam Sterilization

[18032568036657]

Moist Heat or Steam Sterilization

[18032568036657]

Moist Heat or Steam Sterilization

[18032568036657]

Moist Heat or Steam Sterilization

[18032568036657]

Moist Heat or Steam Sterilization

[18032568036657]

Moist Heat or Steam Sterilization

[18032568036657]

Moist Heat or Steam Sterilization

[18032568036657]

Moist Heat or Steam Sterilization

[18032568036657]

Moist Heat or Steam Sterilization

[18032568036657]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-01

On-Brand Devices [PAEDIATRIC LIMB RECONSTRUCTION SYSTEM ]

18033509858284PAEDIATRIC LRS STRAIGTH CLAMP
18033509858277PAEDIATRIC LRS HINGE CONNECTION
18032568864632PAEDIATRIC SANDWICH CLAMP KIT
18032568036817HINGED RAIL COUPLING FOR PAEDIATRIC LRS
18032568036800SWIVELLING CLAMP FOR PAEDIATRIC LRS
18032568036794LOCKING SCREW FOR PAEDIATRIC LRS
18032568036787LONG RAIL LENGTH 25 CM FOR PAEDIATRIC LRS
18032568036770STANDARD RAIL LENGTH 20 CM FOR PAEDIATRIC LRS
18032568036763SHORT RAIL LENGTH 15 CM FOR PAEDIATRIC LRS
18032568036756EXTRA-SHORT RAIL LENGTH 10 CM FOR PAEDIATRIC LRS
18032568036749STRAIGHT CLAMP FOR PAEDIATRIC LRS
18032568036732BALL-JOINT COUPLING FOR PAEDIATRIC LRS
18032568036725DYNA-RING WITH C/D UNIT ATTACH FOR PAEDIATRIC LRS
18032568036695OF-GARCHES T-CLAMP KIT FOR PAEDIATRIC LRS
18032568036688PAEDIATRIC LRS T-CLAMP
18032568036671PAEDIATRIC LRS LONG KIT
18032568036664PAEDIATRIC LRS STANDARD KIT
18032568036657PAEDIATRIC LRS C/D UNIT EXTENDS TO 6.2 CM
18032568036640PAEDIATRIC LRS SHORT KIT
18032568033502TEMPLATE LOCKING SCREW PAEDIATRIC LRS
18032568033496BALL-JOINT COUPLING TEMPLATE PAEDIATRIC LRS
18032568033489SWIVELLING CLAMP TEMPLATE PAEDIATRIC LRS
18032568033472T-CLAMP TEMPLATE PAEDIATRIC LRS
18032568033465STRAIGHT CLAMP TEMPLATE PAEDIATRIC LRS
18032568032819PAEDIATRIC LRS STERI BOX EMPTY
18053504369998Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504369813Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504369806Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504369714Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504369707Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504369684Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504369677Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504369660Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504369653Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504366355Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504366348Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504366331Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504366324Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504366300Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504365372Component. Not for sale. Used for reporting Direct Marking of assembly.
18053504364726Component. Not for sale. Used for reporting Direct Marking of assembly.
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