JAZZ System 350684

GUDID 03607503506847

IMPLANET

Trans-facet-screw internal spinal fixation system, sterile
Primary Device ID03607503506847
NIH Device Record Key87062c0f-fa90-4fcd-80a7-3558ab24121a
Commercial Distribution StatusIn Commercial Distribution
Brand NameJAZZ System
Version Model NumberJazz Rod - Straight Union Rod Dia.6.0 L120
Catalog Number350684
Company DUNS291993439
Company NameIMPLANET
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Length120 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103607503506847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-09-26
Device Publish Date2019-03-20

On-Brand Devices [JAZZ System]

03607505503516Round passer R20
03607505503509Straight Passer-30mm
03607505500621Cap SP Tensioner Stem
03607503502603JAZZ Evo – 6mm Connector Kit
03607503502580JAZZ Evo – 5.5mm Connector Kit
03607503502566JAZZ Evo – 5mm Connector Kit
03607503501576JAZZ Passer Band
03607505504032Hexagonal 3,5 Evo Screwdriver
03607505504025JAZZ CLAW – Instruments Container - Lid
03607505504018JAZZ CLAW – Instruments Container - Basis
03607505500638Cap SP anti-torque wrench
03607505502953Tensioner Gen. II
03607505500591Snapping Forceps
03607505500577Forceps
03607505500560Tensioner
03607503507189Pre-bent Rod Dia. 4/5.5 L70 - CoCr
03607503507172Pre-bent Rod Dia. 4/5.5 L70
03607503507165Straight Rod Dia. 4/5.5 L70 - CoCr
03607503507158Straight Rod Dia. 4/5.5 L70
03607503507141Hook Left Large
03607503507134Hook Right Large
03607503507127Hook Left
03607503507110Hook Right
03607503507103Connector
03607503506946JAZZ Cap SP, H14
03607503506922JAZZ Cap SP, H12
03607503506908JAZZ Cap SP, H10
03607503506885Jazz Rod - Straight Union Rod Dia.6.0 L400
03607503506878Jazz Rod - Straight Union Rod Dia.6.0 L300
03607503506861Jazz Rod - Straight Union Rod Dia.6.0 L200
03607503506854Jazz Rod - Straight Union Rod Dia.6.0 L160
03607503506847Jazz Rod - Straight Union Rod Dia.6.0 L120
03607503506830Jazz Rod - Straight Union Rod Dia.6.0 L110
03607503506823Jazz Rod - Pre-bent Union Rod Dia.6.0 L100
03607503506816Jazz Rod - Pre-bent Union Rod Dia.6.0 L90
03607503506809Jazz Rod - Pre-bent Union Rod Dia.6.0 L80
03607503506793Jazz Rod - Pre-bent Union Rod Dia.6.0 L70
03607503506786Jazz Rod - Pre-bent Union Rod Dia.6.0 L60
03607503506779Jazz Rod - Pre-bent Union Rod Dia.6.0 L50
03607503506762Jazz Rod - Pre-bent Union Rod Dia.6.0 L40
03607503506755Jazz Rod - Pre-bent Union Rod Dia.6.0 L30
03607503506731Jazz Rod - Straight Union Rod – L400
03607503506724Jazz Rod - Straight Union Rod – L300
03607503506717Jazz Rod - Straight Union Rod – L200
03607503506700Jazz Rod - Straight Union Rod – L160
03607503506694Jazz Rod - Straight Union Rod – L120
03607503506687Jazz Rod - Straight Union Rod – L110
03607503506670Jazz Rod - Pre-bent Union Rod – L100
03607503506663Jazz Rod - Pre-bent Union Rod – L90
03607503506656Jazz Rod - Pre-bent Union Rod – L80

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