Procallus Fixator 99-90046

GUDID 18032568863246

RADIOLUCENT ANKLE CLAMP STERILE

ORTHOFIX SRL

External orthopaedic fixation system, reusable
Primary Device ID18032568863246
NIH Device Record Key7a416ca5-20d4-4f9c-bf78-bfe88342e22a
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcallus Fixator
Version Model Number1
Catalog Number99-90046
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 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
GS118032568863246 [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

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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