Pointer KNI001

GUDID 03760297030001

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 ID: 03760297030001
• NIH Device Record Key: 6c610d02-dcb8-4007-b63a-86497c97c531
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pointer
• Version Model Number: Knee+
• Catalog Number: KNI001
• Company DUNS: 270195749
• Company Name: PIXEE MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com
• Phone: +33458101365
• Email: contact@pixee-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760297030001 [Primary]

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

[03760297030001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-18
• Device Publish Date: 2021-10-08

Devices Manufactured by PIXEE MEDICAL

• 03760297030223 - SHA Outer ring: 2023-06-26
• 03760297030247 - SHA Connector: 2023-06-26
• 03760297030315 - KneePlus: 2023-06-26 Software for Total Knee Arthroplasty
• 03760297030209 - FX Shoulder Positioning System: 2022-10-24 Planning software for total shoulder arthroplasty
• 03760297030124 - KneePlus: 2022-10-12 Software for Total Knee Arthroplasty
• 03760297030131 - Long Pointer: 2022-10-12 Reusable instrument for Total Knee Arthroplasty
• 03760297030148 - Portal: 2022-10-12 Software for Total Knee Arthroplasty
• 03760297030155 - Slim Bone Reference: 2022-10-12 Reusable instrument for Total Knee Arthroplasty