N/A CS 3829-01

GUDID 04052536123261

Rod inserter with spring, percutaneous for screws, pre-fixation

Ulrich GmbH & Co. KG

General internal orthopaedic fixation system implantation kit
Primary Device ID04052536123261
NIH Device Record Key6d72969d-c007-4a36-a65e-a68cc568ea89
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberCS 3829-01
Catalog NumberCS 3829-01
Company DUNS315494757
Company NameUlrich GmbH & Co. KG
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4907319654152
Emailsafety@ulrichmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104052536123261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04052536123261]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-30

On-Brand Devices [N/A]

04052536184514Pump tubing - flex for ulrichINJECT CT injectors
04052536184088ulrich Transfer Set, 20 in for USA only: For use with Omnipaque Imaging Bulk Package
04052536181216Spike for CT (CM/NaCl) for ulrichINJECT CT injectors
04052536180424Patient tubing 320 cm for Pump tubing - flex
04052536180400Patient tubing 250 cm for Pump tubing - flex
04052536179923Patient tubing 150 cm for Pump tubing - flex
04052536170043OC screwdriver, flexible, self-retaining, coupling AO
04052536170029Rod reduction instrument
04052536169184Screwdriver, cannulated, with SR 15, coupling AO
04052536168972Outer sleeve for rod pusher (persuader)
04052536167326Layer for mambo screws
04052536164622Box for small OC-implants
04052536164615Box for crosslink, screw-screw
04052536164554Carrier for occipital screws
04052536164547Layer 1 for neon³ OC-module
04052536164530Layer 2 for neon³ OC-module
04052536164417Tray for neon³ OC-module
04052536163243Compression forceps, percutaneous
04052536163236Distraction forceps, percutaneous
04052536163137Inner sleeve for rod pusher (persuader)
04052536162055OC plate bender with handle
04052536162031Counterpart for torque wrench
04052536162024Screwdriver with SR 20, self-retaining
04052536161980Rod pusher (Rocker)
04052536161935Rotating end for CS 3932-04
04052536161928Screwdriver, cannulated, with SR 15
04052536136049Layer for tezo addition set
04052536136025Layer 2 for tezo-A instruments
04052536136001Layer 2 for tezo-P/T instruments
04052536135707Tray for mambo implants & instruments
04052536135691Layer for mambo instruments
04052536135684Layer for mambo instruments
04052536135677Layer for mambo implants
04052536123261Rod inserter with spring, percutaneous for screws, pre-fixation
04052536122332Measuring lever
04052536122325Handle for measuring instrument
04052536122271Inserter for pin
04052536122264Fixation pin
04052536122257Plate holder
04052536122240Shaft for screwdriver, torx 15, with 1/4-inch-coupling
04052536122233Shaft for screwdriver, torx 8, with AO-coupling
04052536085866Hook inserting forceps
04052536085811OC plate bending clamp
04052536085798OC-tap, flexible, for CS 3914-50-XX, coupling AO
04052536085781OC-tap, rigid, for CS 3914-50-XX, coupling AO
04052536085705Screwdriver with SR 20, coupling AO
04052536085620Star grip handle for rod pusher (persuader)
04052536085545Screwhead adjuster
04052536085521Sleeve for screwdriver
04052536085484Insert for Brainlab ICM4
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