Set Screw

GUDID 06912547138273

Shandong Weigao Orthopaedic Device Co., Ltd.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID06912547138273
NIH Device Record Keybd25f3a8-a410-4802-a05c-1df29ca56205
Commercial Distribution StatusIn Commercial Distribution
Brand NameSet Screw
Version Model Number8422500
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
GS106912547138273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

Moist Heat or Steam Sterilization


[06912547138273]

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 [Set Screw]

069125473949148421500
069125471382738422500

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