PASS XS

GUDID 03613720248149

Ø5.5 mm x 35 mm POLYAXIAL SCREW

MEDICREA INTERNATIONAL

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID03613720248149
NIH Device Record Keyfea82ab9-6011-4246-8892-3ddcc02f445b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePASS XS
Version Model NumberB19115535
Company DUNS383228632
Company NameMEDICREA INTERNATIONAL
Device Count1
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103613720248149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03613720248149]

Moist Heat or Steam Sterilization


[03613720248149]

Moist Heat or Steam Sterilization


[03613720248149]

Moist Heat or Steam Sterilization


[03613720248149]

Moist Heat or Steam Sterilization


[03613720248149]

Moist Heat or Steam Sterilization


[03613720248149]

Moist Heat or Steam Sterilization


[03613720248149]

Moist Heat or Steam Sterilization


[03613720248149]

Moist Heat or Steam Sterilization


[03613720248149]

Moist Heat or Steam Sterilization


[03613720248149]

Moist Heat or Steam Sterilization


[03613720248149]

Moist Heat or Steam Sterilization


[03613720248149]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-05-23
Device Publish Date2017-01-27

On-Brand Devices [PASS XS]

03613720247166CLAW COUNTER HOOK HOLDER
03613720248712T HANDLE
03613720247104NUT REMOVER
03613720246954ROD HOLDER
03613720246848SCREWDRIVER SHAFT
03613720248903T20 SCREWDRIVER SHAFT, LONG
03613720248736SLIM T HANDLE
03613720248729PALM HANDLE
03613720248705STRAIGHT HANDLE
03613720248699TORQUE LIMITING HANDLE - 4 Nm
03613720248675Ø4.5 mm x 450 mm ROD, CoCr
03613720248668Ø4.5 mm x 440 mm ROD, CoCr
03613720248651Ø4.5 mm x 420 mm ROD, CoCr
03613720248644Ø4.5 mm x 400 mm ROD, CoCr
03613720248637Ø4.5 mm x 380 mm ROD, CoCr
03613720248620Ø4.5 mm x 360 mm ROD, CoCr
03613720248613Ø4.5 mm x 340 mm ROD, CoCr
03613720248606Ø4.5 mm x 320 mm ROD, CoCr
03613720248590Ø4.5 mm x 300 mm ROD, CoCr r
03613720248583Ø4.5 mm x 280 mm ROD, CoCr
03613720248576Ø4.5 mm x 260 mm ROD, CoCr
03613720248569Ø4.5 mm x 240 mm ROD, CoCr
03613720248552Ø4.5 mm x 220 mm ROD, CoCr
03613720248545Ø4.5 mm x 200 mm ROD, CoCr
03613720248538Ø4.5 mm x 180 mm ROD, CoCr
03613720248521Ø4.5 mm x 160 mm ROD, CoCr
03613720248514Ø4.5 mm x 140 mm ROD, CoCr
03613720248507Ø4.5 mm x 120 mm ROD, CoCr
03613720248491Ø4.5 mm x 100 mm ROD, CoCr
03613720248484Ø4.5 mm x 80 mm ROD, CoCr
03613720248477Ø4.5 mm x 60 mm ROD, CoCr
03613720248460CROSSLINK FOR Ø4.5 mm ROD, 10 mm - 37 mm
03613720248453OFFSET CONNECTOR FOR Ø4.5 mm ROD
03613720248446ANGULATED CONNECTOR FOR Ø4.5 mm ROD
03613720248439DRC CONNECTOR FOR Ø4.5 mm ROD
03613720248422STANDARD CONNECTOR FOR Ø4.5 mm ROD
03613720248415BREAK AWAY NUT
03613720248361Ø4.5 mm x 450 mm ROD, Ti
03613720248354Ø4.5 mm x 440 mm ROD, Ti
03613720248347Ø4.5 mm x 420 mm ROD, Ti
03613720248330Ø4.5 mm x 400 mm ROD, Ti
03613720248323Ø4.5 mm x 380 mm ROD, Ti
03613720248316Ø4.5 mm x 360 mm ROD, Ti
03613720248309Ø4.5 mm x 340 mm ROD, Ti
03613720248293Ø4.5 mm x 320 mm ROD, Ti
03613720248286Ø4.5 mm x 300 mm ROD, Ti
03613720248279Ø4.5 mm x 280 mm ROD, Ti
03613720248262Ø4.5 mm x 260 mm ROD, Ti
03613720248255Ø4.5 mm x 240 mm ROD, Ti
03613720248248Ø4.5 mm x 220 mm ROD, Ti

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