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

Basic Information

• Brand Name: Navigated Targeting Needle SPX1, Trocar tip – 11G, 125 mm
• Primary DI: 03701311501039
• Version / Model: A01028
• Company Name: ECENTIAL ROBOTICS
• Labeler DUNS: 261610964
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-04
• Public Version: 1
• Public Version Date: 2023-09-12
• Public Version Status: New
• Public Device Record Key: dff15738-4619-454e-9894-f454ce9868e5

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OLO	Orthopedic Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60478	Bone access cannula	A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.	No	Active
45170	Stereotactic surgery system probe, single-use	A slender, rod-like, hand-held manual surgical instrument intended for use during image-guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip with that of a targeted tissue of interest in a patient so the tissue area is precisely identified with respect to diagnostic images stored in the stereotactic surgery system. It is made of metal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03701311501039	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K221028	000