PROCALLUS FIXATOR 90000

GUDID 18032568860986

PROCALLUS STANDARD FIXATOR KIT

ORTHOFIX SRL

External orthopaedic fixation system, reusable
Primary Device ID18032568860986
NIH Device Record Key9df2f524-a2b6-4590-9164-6c832c6c59cd
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROCALLUS FIXATOR
Version Model Number1
Catalog Number90000
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
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
GS118032568860986 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18032568860986]

Moist Heat or Steam Sterilization

[18032568860986]

Moist Heat or Steam Sterilization

[18032568860986]

Moist Heat or Steam Sterilization

[18032568860986]

Moist Heat or Steam Sterilization

[18032568860986]

Moist Heat or Steam Sterilization

[18032568860986]

Moist Heat or Steam Sterilization

[18032568860986]

Moist Heat or Steam Sterilization

[18032568860986]

Moist Heat or Steam Sterilization

[18032568860986]

Moist Heat or Steam Sterilization

[18032568860986]

Moist Heat or Steam Sterilization

[18032568860986]

Moist Heat or Steam Sterilization

[18032568860986]

Moist Heat or Steam Sterilization

[18032568860986]

Moist Heat or Steam Sterilization

[18032568860986]

Moist Heat or Steam Sterilization

[18032568860986]

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

On-Brand Devices [PROCALLUS FIXATOR ]

18053504367055PROCALLUS FIXATOR HYBRID CONNECTION
18053504360902DISTAL HUMERAL CLAMP
18032937168057ARTICULATED BODY FOR HEMICALLOTASIS
18032568867268PROCALLUS SYSTEM STERIBOX, EMPTY
18032568867251PROCALLUS SYSTEM WITH ACTUATOR STERIBOX, EMPTY
18032568867244PROCALLUS SYSTEM INSTRUMENT STERIBOX, EMPTY
18032568866599SUPPLEMENTARY SCREW HOLDER CLAMP
18032568861303ELBOW EXTENDED RANGE CLAMP
18032568861273RADIOLUCENT ANKLE CLAMP
18032568861266ARTICULATION LOCKING NUT FOR RADIOLUCENT ANKLE CLAMP
18032568861242SELF-ALIGNING ARTICULATED BODY FOR PROCALLUS
18032568861235SELF-ALIGN ARTIC BODY ASSEMBLY KIT FOR PROCALLUS
18032568861228CENTRAL BODY FEMALE COMPONENT FOR SHORT PROCALLUS
18032568861211CENTRAL BODY MALE COMPONENT FOR SHORT PROCALLUS
18032568861204PROCALLUS SHORT ACTUATOR EXTENDS TO 2.75 CM
18032568861198PROCALLUS SHORT CENTRAL BODY
18032568861181PROCALLUS SHORT FIXATOR KIT WITH ACTUATOR
18032568861174PROCALLUS SHORT FIXATOR KIT
18032568861167ARTICULATED BODY FOR THE HIP FOR PROCALLUS
18032568861150CENTRAL BODY FEMALE COMPONENT FOR LONG PROCALLUS
18032568861143CENTRAL BODY MALE COMPONENT FOR LONG PROCALLUS
18032568861136CENTRAL BODY FEMALE COMPONENT FOR STANDARD PROCALLUS
18032568861129CENTRAL BODY MALE COMPONENT FOR STANDARD PROCALLUS
18032568861112CENTRAL BODY LOCKING NUT FOR PROCALLUS
18032568861105MICROMOVEMENT LOCKING NUT FOR PROCALLUS
18032568861099PROCALLUS CLAMP SCREW
18032568861082PROCALLUS LONG ACTUATOR EXTENDS TO 8 CM
18032568861068PROCALLUS T-CLAMP
18032568861051PROCALLUS STRAIGHT CLAMP
18032568861044BUSH
18032568861037PROCALLUS LONG BODY
18032568861020PROCALLUS STANDARD BODY
18032568861013PROCALLUS LONG FIXATOR KIT WITH ACTUATOR
18032568861006PROCALLUS LONG FIXATOR KIT
18032568860993PROCALLUS STANDARD FIXATOR KIT WITH ACTUATOR
18032568860986PROCALLUS STANDARD FIXATOR KIT
18032568032703RADIOLUCENT ANKLE PIN GUIDE
18032568032567PROCALLUS ASSEMBLY KIT
18032568032550TORBAY-GARCHES CLAMP TEMPLATE RADIOLUCENT
18032568032505METAPHYSEAL CLAMP TEMPLATE
18032568032475ANGLED CLAMP TEMPLATE
18032568032352DRILL GUIDE DIAMETER 4.8 MM LENGTH 140 MM
18032568032345SCREW GUIDE LENGTH 160 MM
18032568030624TORBAY-GARCHES CLAMP
18032568030556CLAMP COVER FOR ANGLED CLAMP
18032568030549METAPHYSEAL CLAMP
18032568030518ANGLED CLAMP
18053504369844Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504369783Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
18053504369776Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.
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