Procallus Fixator 11014

GUDID 18032568032086

X-WIRE WITHOUT OLIVE DIAMETER 1.5 MM LENGTH 250 MM

ORTHOFIX SRL

Orthopaedic bone wire
Primary Device ID18032568032086
NIH Device Record Keyaa324c38-3079-4850-8a39-983a19dd6e6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcallus Fixator
Version Model Number1
Catalog Number11014
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

Length250 Millimeter
Outer Diameter1.5 Millimeter
Length250 Millimeter
Outer Diameter1.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118032568032086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18032568032086]

Moist Heat or Steam Sterilization


[18032568032086]

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 [Procallus Fixator]

18032568863277RADIOLUCENT ANKLE CLAMP KIT STERILE
18032568863246RADIOLUCENT ANKLE CLAMP STERILE
18032568032086X-WIRE WITHOUT OLIVE DIAMETER 1.5 MM LENGTH 250 MM

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