Multi-Axial Reduction Screw

GUDID 06912547393306

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID06912547393306
NIH Device Record Key6e5fcd65-9d57-4825-829c-1ae752c89230
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti-Axial Reduction Screw
Version Model Number8228025
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
GS106912547393306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

Moist Heat or Steam Sterilization


[06912547393306]

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 [Multi-Axial Reduction Screw]

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069394883314408227560
069394883314338227555
069394883314268227550
069394883314198227545
069394883314028227540
069394883313968227535
069394883313898227530
069394883313728227525
069394883313658227065
069394883313588227060
069394883313418227055
069394883313348227050
069394883313278227045
069394883313108227040
069394883313038227035
069394883312978227030
069394883312808227025
069394883312738226565
069394883312668226560
069394883312598226555
069394883312428226550
069394883312358226545
069394883312288226540
069394883312118226535
069394883312048226530
069394883311988226525
069394883311818226065
069394883311748226060
069394883311678226055
069394883311508226050
069394883311438226045
069394883311368226040
069394883311298226035
069394883311128226030
069394883311058226025
069394883310998225555
069394883310828225550
069394883310758225545
069394883310688225540
069394883310518225535
069394883310448225530
069394883310378225525
069394883310208225055
069394883310138225050
069394883310068225045
069394883309938225040
069394883309868225035
069394883309798225030
069394883309628225025

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