Planar Screw

GUDID 06912547086345

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID06912547086345
NIH Device Record Key47124d07-bd0a-4fd6-9d23-023903afcf17
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlanar Screw
Version Model Number8264520
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
GS106912547086345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


[06912547086345]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-05

On-Brand Devices [Planar Screw]

069394883327998267565
069394883327828267560
069394883327758267555
069394883327688267550
069394883327518267545
069394883327448267540
069394883327378267535
069394883327208267530
069394883327138267525
069394883327068267065
069394883326908267060
069394883326838267055
069394883326768267050
069394883326698267045
069394883326528267040
069394883326458267035
069394883326388267030
069394883326218267025
069394883326148266565
069394883326078266560
069394883325918266555
069394883325848266550
069394883325778266545
069394883325608266540
069394883325538266535
069394883325468266530
069394883325398266525
069394883325228266065
069394883325158266060
069394883325088266055
069394883324928266050
069394883324858266045
069394883324788266040
069394883324618266035
069394883324548266030
069394883324478266025
069394883324308265555
069394883324238265550
069394883324168265545
069394883324098265540
069394883323938265535
069394883323868265530
069394883323798265525
069394883323628265055
069394883323558265050
069394883323488265045
069394883323318265040
069394883323248265035
069394883323178265030
069394883323008265025

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