Universal Cutting Guide KNI008

GUDID 03760297030063

Reusable instrument for Total Knee Arthroplasty

PIXEE MEDICAL

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID03760297030063
NIH Device Record Key91960837-9c9f-4836-b472-8b24bcaeb2c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Cutting Guide
Version Model NumberKnee+
Catalog NumberKNI008
Company DUNS270195749
Company NamePIXEE MEDICAL
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 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+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com
Phone+33458101365
Emailcontact@pixee-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103760297030063 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


[03760297030063]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-18
Device Publish Date2021-10-08

Devices Manufactured by PIXEE MEDICAL

03760297030223 - SHA Outer ring2023-06-26
03760297030247 - SHA Connector2023-06-26
03760297030315 - KneePlus2023-06-26 Software for Total Knee Arthroplasty
03760297030209 - FX Shoulder Positioning System2022-10-24 Planning software for total shoulder arthroplasty
03760297030124 - KneePlus2022-10-12 Software for Total Knee Arthroplasty
03760297030131 - Long Pointer2022-10-12 Reusable instrument for Total Knee Arthroplasty
03760297030148 - Portal2022-10-12 Software for Total Knee Arthroplasty
03760297030155 - Slim Bone Reference2022-10-12 Reusable instrument for Total Knee Arthroplasty

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