ELBOW FIXATOR 111807

GUDID 18053504364795

Component. Not for sale. Used for reporting Direct Marking of assembly.

ORTHOFIX SRL

External orthopaedic fixation system, reusable
Primary Device ID18053504364795
NIH Device Record Keyad22cfc4-2ce0-4e40-9da1-726e5bff67e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameELBOW FIXATOR
Version Model Number1
Catalog Number111807
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

Device Identifiers

Device Issuing AgencyDevice ID
GS118053504364795 [Primary]

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18053504364795]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-29
Device Publish Date2019-04-19

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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