RADIOLUCENT WRIST FIXATOR SS36900

GUDID 18032568864526

EXTRA SHORT RADIOLUCENT FIXATOR

ORTHOFIX SRL

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID18032568864526
NIH Device Record Keydab403dc-0870-4282-91e2-55ec5b9c06b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameRADIOLUCENT WRIST FIXATOR
Version Model Number1
Catalog NumberSS36900
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 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
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it
Phone+0390456719000
Emailinfo@orthofix.it

Device Identifiers

Device Issuing AgencyDevice ID
GS118032568864526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


[18032568864526]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-19

On-Brand Devices [RADIOLUCENT WRIST FIXATOR]

18032568866384RADIOLUCENT WRIST FIXATOR KIT STERILE, WITH COATED SCREWS
18032568864526EXTRA SHORT RADIOLUCENT FIXATOR
18032568861655RADIOLUCENT WRIST FIXATOR STERILE
18032568861648RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM - STERILE
18032568861624RADIOLUCENT WRIST FIXATOR KIT BASIC SYSTEM - STERILE
18032568039276RADIOLUCENT WRIST FIXATOR AND SCREWS - STERILE
18032568036060SELFDRILLING PIN 80/25 MM THREAD DIA. 3.3/3 MM
18032568036053SELFDRILLING PIN 70/20 MM THREAD DIA. 3.3/3 MM
18032568036015ALLEN WRENCH 4 MM

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