Fixed-Angle Screw

GUDID 06939488395480

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID06939488395480
NIH Device Record Key93eab5fa-4b3a-4d0c-a09f-23bb1a5baabb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixed-Angle Screw
Version Model Number8234530
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
GS106939488395480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

Moist Heat or Steam Sterilization


[06939488395480]

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 [Fixed-Angle Screw]

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069394883960298237560
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069394883960058237550
069394883959928237545
069394883959858237540
069394883959788237535
069394883959618237530
069394883959548237525
069394883959478237065
069394883959308237060
069394883959238237055
069394883959168237050
069394883959098237045
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069394883958868237035
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069394883958628237025
069394883958558236565
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069394883958008236540
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069394883956958236030
069394883956888236025
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069394883956578235545
069394883956408235540
069394883956338235535
069394883956268235530
069394883956198235525
069394883956028235055
069394883955968235050
069394883955898235045
069394883955728235040
069394883955658235035
069394883955588235030
069394883955418235025

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