LOSPA Knee System, EXULT Knee System

GUDID 08800068981486

Patella Clamp Stylus

Corentec Co., Ltd

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Primary Device ID08800068981486
NIH Device Record Keycaa6a2aa-383d-4365-9cae-9d0dd59f832a
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOSPA Knee System, EXULT Knee System
Version Model NumberKA.CPM.0002B
Company DUNS688739895
Company NameCorentec Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com
Phone+820269374902
Emailra@corentec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800068981486 [Primary]

FDA Product Code

LHXTrousers, Anti-Shock

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


[08800068981486]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-22
Device Publish Date2024-01-12

On-Brand Devices [LOSPA Knee System, EXULT Knee System]

08800068981486Patella Clamp Stylus
08800017205267Patella Clamp Resection Guide Head 2
08800017205250Patella Clamp Resection Guide Head 1
08800017204871Patella Peg Drill

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