XCALIBER EXTERNAL FIXATOR 19200

GUDID 18032568035216

XCALIBER MANIPULATION FORCEPS

ORTHOFIX SRL

External orthopaedic fixation system, reusable
Primary Device ID18032568035216
NIH Device Record Key00990336-0bcd-4b8b-8d7a-7e42553dd432
Commercial Distribution StatusIn Commercial Distribution
Brand NameXCALIBER EXTERNAL FIXATOR
Version Model Number1
Catalog Number19200
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

Device Identifiers

Device Issuing AgencyDevice ID
GS118032568035216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18032568035216]

Moist Heat or Steam Sterilization


[18032568035216]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-24

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18032937167791US XCALIBER ANKLE COMPLETE KIT
18032937167784US XCALIBER METADIAPHYSEAL COMPLETE KIT
18032568867299XCALIBER/PROCALLUS HYBRID INSTRUMENTS STERIBOX, EMPTY
18032568867282XCALIBER META-DIAPHYSEAL/ANKLE INSTRUMENTS STERIBOX, EMPTY
18032568867213XCALIBER ARTICULATED ANKLE KIT WITH DYNAMIC C/D UNIT STERILE
18032568867206XCALIBER META-DIAPHYSEAL KIT WITH DYNAMIC C/D UNIT STERILE
18032568863352XCALIBER HYBRID KIT STERILE
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18032568863338SUPPLEMENTARY SCREW HOLDER (BARS AND CLAMPS) STERILE
18032568863321XCALIBER DYNAMIC C/D UNIT STERILE
18032568863307XCALIBER META-DIAPHYSEAL KIT STERILE
18032568861617RADIOLUCENT ANKLE PIN GUIDE STERILE
18032568861600CANNULATED DRILL BIT WITH WIRE D 3.2 MM LENGTH 150 MM STERILE
18032568861358SUPPLEMENTARY SCREW HOLDER BAR RADIOLUCENT 150 MM
18032568861341UNIVERSAL ALLEN WRENCH
18032568861259SUPPLEMENTARY SCREW HOLDER
18032568035216XCALIBER MANIPULATION FORCEPS
18053504369752Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.

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