Xcaliber External Fixator 99-91600JP

GUDID 18032937169689

JP XCALIBER METADIAPHYSEAL COMPLETE KIT

ORTHOFIX SRL

External orthopaedic fixation system, single-use, sterile
Primary Device ID18032937169689
NIH Device Record Key75c9f84a-f235-436c-8fe4-70c3621d34a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameXcaliber External Fixator
Version Model Number1
Catalog Number99-91600JP
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 Datetrue
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 Identifiers

Device Issuing AgencyDevice ID
GS118032937169689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-01

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18032568863338SUPPLEMENTARY SCREW HOLDER (BARS AND CLAMPS) STERILE
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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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