Elbow Fixator 11146

GUDID 18032568032536

X-WIRE WITHOUT OLIVE DIAMETER 2 MM LENGTH 150 MM

ORTHOFIX SRL

Orthopaedic bone wire
Primary Device ID18032568032536
NIH Device Record Key20fd3c18-55a1-4758-83da-4daeebd7c702
Commercial Distribution StatusIn Commercial Distribution
Brand NameElbow Fixator
Version Model Number1
Catalog Number11146
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 Numbertrue
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+039456719000
Emailinfo@orthofix.it
Phone+039456719000
Emailinfo@orthofix.it

Device Dimensions

Outer Diameter2 Millimeter
Length150 Millimeter
Outer Diameter2 Millimeter
Length150 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118032568032536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18032568032536]

Moist Heat or Steam Sterilization


[18032568032536]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [Elbow Fixator]

18032568032840ELBOW FIXATOR STERI BOX EMPTY
18032568032536X-WIRE WITHOUT OLIVE DIAMETER 2 MM LENGTH 150 MM
18032568030785SHORT PRIMARY LINK
18032568030778CD UNIT SPACERS (1 PAIR) FOR ELBOW FIXATOR
18032568030747ELBOW FIXATOR CENTRAL BODY
18032568030730LINK LOCKING SCREW FOR ELBOW FIXATOR
18032568030723SMALL DISTRACTOR FOR ELBOW FIXATOR
18032568030716CENTRAL CONNECTING UNIT FOR ELBOW FIXATOR
18032568030709ELBOW FIXATOR WITH PROCALLUS STRAIGHT CLAMPS
18053504365679Component. Not for sale. Used for reporting Direct Marking of assembly.
18053504364825Component. Not for sale. Used for reporting Direct Marking of assembly.
18053504364818Component. Not for sale. Used for reporting Direct Marking of assembly.
18053504364801Component. Not for sale. Used for reporting Direct Marking of assembly.
18053504364795Component. Not for sale. Used for reporting Direct Marking of assembly.
18032568868739Component. Not for sale. Used for reporting Direct Marking of assembly.

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