Planar Reduction Screw

GUDID 06912547395300

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID06912547395300
NIH Device Record Key11cd8776-9c11-408e-ac70-65ef968884d0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlanar Reduction Screw
Version Model Number803607050
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
GS106912547395300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


[06912547395300]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-12-12

On-Brand Devices [Planar Reduction Screw]

06912547395423803607565
06912547395416803607560
06912547395409803607555
06912547395393803607550
06912547395386803607545
06912547395379803607540
06912547395362803607535
06912547395355803607530
06912547395348803607525
06912547395331803607065
06912547395324803607060
06912547395317803607055
06912547395300803607050
06912547395294803607045
06912547395287803607040
06912547395270803607035
06912547395263803607030
06912547395256803607025
06912547395249803606565
06912547395232803606560
06912547395225803606555
06912547395218803606550
06912547395201803606545
06912547395195803606540
06912547395188803606535
06912547395171803606530
06912547393801803606525
06912547393795803606065
06912547393788803606060
06912547393771803606055
06912547393764803606050
06912547393757803606045
06912547393740803606040
06912547393733803606035
06912547393726803606030
06912547393719803606025
06912547393702803605555
06912547393696803605550
06912547393689803605545
06912547393672803605540
06912547393665803605535
06912547393658803605530
06912547393641803605525
06912547393634803605055
06912547393627803605050
06912547393610803605045
06912547393603803605040
06912547393597803605035
06912547393580803605030
06912547393573803605025

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