Multi-Axial Screw

GUDID 06939488395404

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID06939488395404
NIH Device Record Key5e388c7b-aa11-414e-b17d-3fbdf35b5bb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti-Axial Screw
Version Model Number8217565
Company DUNS545249039
Company NameShandong Weigao Orthopaedic Device Co., Ltd.
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106939488395404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06939488395404]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

On-Brand Devices [Multi-Axial Screw]

069394883954048217565
069394883953988217560
069394883953818217555
069394883953748217550
069394883953678217545
069394883953508217540
069394883953438217535
069394883953368217530
069394883953298217525
069394883953128217065
069394883953058217060
069394883952998217055
069394883952828217050
069394883952758217045
069394883952688217040
069394883952518217035
069394883952448217030
069394883952378217025
069394883952208216565
069394883952138216560
069394883952068216555
069394883951908216550
069394883951838216545
069394883951768216540
069394883951698216535
069394883951528216530
069394883951458216525
069394883951388216065
069394883951218216060
069394883951148216055
069394883951078216050
069394883950918216045
069394883950848216040
069394883950778216035
069394883950608216030
069394883950538216025
069394883950468215555
069394883950398215550
069394883950228215545
069394883950158215540
069394883950088215535
069394883949958215530
069394883949888215525
069394883949718215055
069394883949648215050
069394883949578215045
069394883949408215040
069394883949338215035
069394883949268215030
069394883949198215025

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