ILIZAROV SYSTEMS 102706

GUDID 28033201841994

WASHER 2.0MM FIXATION BOLT

MEDICALPLASTIC SRL

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID28033201841994
NIH Device Record Key8d28fa8b-c85e-44ae-a380-bf69fbbd00fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameILIZAROV SYSTEMS
Version Model Number102706
Catalog Number102706
Company DUNS434581062
Company NameMEDICALPLASTIC SRL
Device Count20
DM Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033201841990 [Unit of Use]
GS128033201841994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPIN, FIXATION, THREADED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


[28033201841994]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-30
Device Publish Date2016-10-21

On-Brand Devices [ILIZAROV SYSTEMS]

2803320184252630mm THREADED ROD
28033201842311RUSSIAN WIRE FIXATION BOLT
28033201842267CONICAL WASHER COUPLE
28033201842007WASHER 4.0MM FIXATION BOLT
28033201841994WASHER 2.0MM FIXATION BOLT
28033201841987WASHER 2 MM
28033201841963WASHER SLOTTED
28033201841918THREADED ROD SLOTTED 100MM LENGTH
28033201841901THREADED ROD SLOTTED 80MM LENGTH
28033201841895THREADED ROD SLOTTED 60MM LENGTH
28033201841888THREADED ROD SLOTTED 40MM LENGTH
28033201841871THREADED ROD 400MM LENGTH
28033201841864THREADED ROD 350MM LENGTH
28033201841857THREADED ROD 300MM LENGTH
28033201841840THREADED ROD 250MM LENGTH
28033201841826THREADED ROD 200MM LENGTH
28033201841819THREADED ROD 150MM LENGTH
28033201841802THREADED ROD 120MM LENGTH
28033201841796THREADED ROD 100MM LENGTH
28033201841789THREADED ROD 80MM LENGTH
28033201841772THREADED ROD 60MM LENGTH
280332018417651,8 MM DIA 400 MM LENGTH ST. STEEL WIRE WITH STOPPER, BAYONET POINT
280332018417271.8 MM DIA 370 MM LENGTH ST. STEEL ILIZAROV WIRE CORTICAL, BAYONET POINT
280332018417101,5 MM DIA 300 MM LENGTH ST. STEEL ILIZAROV WIRE CORTICAL, BAYONET POINT
08033201842539ILIZAROV SHOULDER BOLT
28033201842335LONG WIRE FIXATION BOLT-CANNULATED
28033201842328LONG WIRE FIXATION BOLT-SLOTTED
08033201842256OBLIQUE SUPPORT CONNECTION
08033201842232ADJUSTABLE PIN FIXATION CLAMP
08033201842225SINGLE PIN FIXATION BOLT AND NUT
08033201842195120 DEGREE ARCH LARGE
0803320184218890 DEGREE ARCH LARGE
08033201842171120 DEGREE ARCH SMALL
0803320184216490 DEGREE ARCH SMALL
080332018421574 POINT DISTRACTION / COMPRESSION COUNTER
08033201841945UNIVERSAL JOINT
08033201841938HINGE 90 DEGREES HIGH PROFILE
08033201841921HINGE 90 DEGREE LOW PROFILE
08033201841709CURVED PLATE 3 HOLES
08033201841693TWISTED PLATE 4 HOLES
08033201841686TWISTED PLATE 3 HOLES
08033201841679TWISTED PLATE 2 HOLES
08033201841662SHORT CONNECTION PLATE 35MM
08033201841655SHORT CONNECTION PLATE 115MM
08033201841648SHORT CONNECTION PLATE 105MM
08033201841631SHORT CONNECTION PLATE 95MM
08033201841624SHORT CONNECTION PLATE 85MM
08033201841617SHORT CONNECTION PLATE 75MM
08033201841600SHORT CONNECTION PLATE 65MM
08033201841594SHORT CONNECTION PLATE 55MM

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