Navigated Targeting Needle SPX1, Trocar tip – 11G, 125 mm

GUDID 03701311501039

ECENTIAL ROBOTICS

Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula

• Primary Device ID: 03701311501039
• NIH Device Record Key: dff15738-4619-454e-9894-f454ce9868e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigated Targeting Needle SPX1, Trocar tip – 11G, 125 mm
• Version Model Number: A01028
• Company DUNS: 261610964
• Company Name: ECENTIAL ROBOTICS
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com
• Phone: +33458005520
• Email: service@ecential-robotics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701311501039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221028

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-12
• Device Publish Date: 2023-09-04

Devices Manufactured by ECENTIAL ROBOTICS

• 03701311501374 - Patient Tracker SPX1: 2023-12-25
• 03701311500940 - 3D Imaging Set SPX1: 2023-09-14
• 03701311500704 - CoBot, Drill Bit: 2023-09-12
• 03701311500711 - CoBot, Drill Guide – Sleeve: 2023-09-12
• 03701311500728 - CoBot, Drill Guide – Cortical tip: 2023-09-12
• 03701311500735 - 3.5 mm Hex Head Screwdriver: 2023-09-12
• 03701311500742 - Fixation screw: 2023-09-12
• 03701311500759 - CoBot, Tool Holder: 2023-09-12