Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125mm

GUDID 03701311500056

ECENTIAL ROBOTICS

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• Primary Device ID: 03701311500056
• NIH Device Record Key: 4af3a758-f646-4acd-968b-c687fb1be9f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125mm
• Version Model Number: A00020
• 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: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com
• Phone: +3345800552
• Email: service@ecential-robotics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701311500056 [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: 2023-03-09
• Device Publish Date: 2023-03-01

On-Brand Devices [Navigated Targeting Needle SPX1, Bevel Tip - 11G, 125mm]

• 03701311500056: A00020
• 03701311501015: A01020