DYNAMIC AXIAL FIXATOR 111501

GUDID 18053504364702

Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.

ORTHOFIX SRL

External orthopaedic fixation system, reusable
Primary Device ID18053504364702
NIH Device Record Key45337587-fe96-4459-b73f-ae8e0d2bed77
Commercial Distribution StatusIn Commercial Distribution
Brand NameDYNAMIC AXIAL FIXATOR
Version Model Number1
Catalog Number111501
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

Device Identifiers

Device Issuing AgencyDevice ID
GS118053504364702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPin, Fixation, Threaded

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18053504364702]

Moist Heat or Steam Sterilization

[18053504364702]

Moist Heat or Steam Sterilization

[18053504364702]

Moist Heat or Steam Sterilization

[18053504364702]

Moist Heat or Steam Sterilization

[18053504364702]

Moist Heat or Steam Sterilization

[18053504364702]

Moist Heat or Steam Sterilization

[18053504364702]

Moist Heat or Steam Sterilization

[18053504364702]

Moist Heat or Steam Sterilization

[18053504364702]

Moist Heat or Steam Sterilization

[18053504364702]

Moist Heat or Steam Sterilization

[18053504364702]

Moist Heat or Steam Sterilization

[18053504364702]

Moist Heat or Steam Sterilization

[18053504364702]

Moist Heat or Steam Sterilization

[18053504364702]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-29
Device Publish Date2019-04-19

On-Brand Devices [DYNAMIC AXIAL FIXATOR]

18054242511823CANNULATED DRILL BIT KIT L 250 MM D 4.8 MM 2.2 MM HOLE
18054242511557CALIBRATED DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT
18054242510901DRILL BIT D.3,2 MM L.140 MM TIN COATED - QUICK CONNECT
18054242510871DRILL BIT D.2,9 MM L.140 MM TIN COATED - QUICK CONNECT
18033509856099DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT
18033509856082DRILL BIT D.1,6 MM L.90 MM TIN COATED - QUICK CONNECT
18033509856075DRILL BIT D.3,2 MM L.200 MM TIN COATED - QUICK CONNECT
18033509856068DRILL BIT D.4,8 MM L.240 MM TIN COATED - QUICK CONNECT
18033509856013CANNULATED DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT STERILE
18033509856006CANNULATED DRILL BIT D.3,2 MM L.200 MM TIN COATED - QUICK CONNECT STERILE
18032937169672CALIBRATED DRILL BIT D.4,8 MM L.190 MM TIN COATED - QUICK CONNECT
18032937169665CANNULATED DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT
18032568868616TEMPLATE FOR HEMI-CALLOTASIS DEVICE
18032568867671CALIBRATED DRILL BIT D. 4.8 MM L.280 MM
18032568867664CALIBRATED DRILL BIT D. 4.8 MM L.180 MM
18032568866575KIT MANIGLIONE ORIENTABILE
18032568866223ALIGNMENT GRID
18032568864373D.A.F. CENTRAL BODY
18032568864366D.A.F. SHORT CLAMP
18032568864359D.A.F. LONG CLAMP
18032568039610CANNULATED DRILL BIT D.3,2 MM L.200 MM TIN COATED - QUICK CONNECT
18032568039603DRILL BIT D.4,8 MM L.180 MM TIN COATED - QUICK CONNECT
18032568035421OF-GARCHES STANDARD T-CLAMP
18032568035360OF-GARCHES STANDARD LIMB LENGTHENER KIT
18032568035292LONG COMPR/DISTR. UNIT FOR OF-GARCHES EXT. TO 10 CM
18032568035285STANDARD COMPR/DISTR. UNIT FOR OF-GARCHES EXT. TO 5.5 CM
18032568033014TEMPLATE LOCKING SCREW
18032568032918DRILL BIT STOP UNIT D 2.9 MM
18032568032901DRILL BIT DIAMETER 3.2 MM LENGTH 140 MM
18032568032895DRILL BIT KIT DIAMETER 3.2 MM LENGTH 140 MM
18032568032871DRILL BIT KIT DIAMETER 2.9 MM LENGTH 140 MM
18032568032772INSTRUMENTATION STERI BOX EMPTY
18032568032765LOWER EXTREMITY TRAUMA STERI BOX EMPTY
18032568032734TRAUMA STERI BOX EMPTY
18032568032574MANIPULATION FORCEPS SELF LOCKING (DAF & PROCALLUS)
18032568032529RULAND PILOT WIRE GUIDE DIAMETER 2 MM LENGTH 115 MM
18032568032512RULAND PILOT WIRE GUIDE DIAMETER 2 MM LENGTH 75 MM
18032568032499TRAUMA-GARCHES CLAMP TEMPLATE
18032568032482PELVIC SCREW GUIDE LENGTH 100 MM
18032568032444SELF-ALIGNING TEMPLATE FOR ARTIC. BODY FOR THE HIP
18032568032437TEMPLATE ALIGNMENT SUPPORT FOR OF-GARCHES
18032568032413TEMPLATE LOCKING SCREW FOR OF-GARCHES
18032568032390OF-GARCHES ASSEMBLY TEMPLATE
18032568032338SCREW GUIDE LENGTH 45 MM
18032568032314DAF SHORT BODY TEMPLATE
18032568032284HAMMER LOCKING NUT
18032568032277DRILL GUIDE DIAMETER 3.2 MM LENGTH 80 MM
18032568032239HAMMER INTERCHANGEABLE HEAD
18032568032222HAMMER
18032568032215TEMPLATE LOCKING SCREW
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