Iliac Screws

GUDID 06912547143703

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID06912547143703
NIH Device Record Key5c63803e-fcc8-4b9b-8ee5-47dd2c56bde1
Commercial Distribution StatusIn Commercial Distribution
Brand NameIliac Screws
Version Model Number803537570
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
GS106912547143703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


[06912547143703]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-15

On-Brand Devices [Iliac Screws]

06912547394440803530510
06912547394433803530505
06912547394426803530500
06912547394419803530595
06912547394402803530590
06912547394396803530585
06912547394389803530580
06912547394372803530575
06912547394365803530570
06912547394358803530565
06912547394341803530560
06912547394334803531010
06912547394327803531005
06912547394310803531000
06912547394303803531095
06912547394297803531090
06912547394280803531085
06912547394273803531080
06912547394266803531075
06912547394259803531070
06912547394242803531065
06912547394235803531060
06912547394228803539510
06912547394211803539505
06912547394204803539500
06912547394198803539595
06912547394181803539590
06912547394174803539585
06912547394167803539580
06912547394150803539575
06912547394143803539570
06912547394136803539565
06912547394129803539560
06912547394112803539010
06912547394105803539005
06912547394099803539000
06912547394082803539095
06912547394075803539090
06912547394068803539085
06912547394051803539080
06912547394044803539075
06912547394037803539070
06912547394020803539065
06912547394013803539060
06912547394006803538500
06912547393993803538595
06912547393986803538570
06912547393979803538565
06912547393962803538560
06912547393955803538000

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