SandShark Injectable Anchor System

Basic Information

• Brand Name: SandShark Injectable Anchor System
• Primary DI: 00850051034581
• Version / Model: SHRK-ALL-1K-US
• Company Name: Curonix LLC
• Labeler DUNS: 118972620
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-04
• Public Version: 1
• Public Version Date: 2023-05-12
• Public Version Status: New
• Public Device Record Key: 3acf6865-9b1b-4ba5-8de1-3b0c632416a3

Device Description

Freedom System Accessories

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: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	882.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64970	Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable	An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included) to relieve acute and/or chronic intractable pain (analgesia). The device is programmed, controlled, and charged telemetrically by external devices.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850051034581	GS1

Premarket Submissions

Submission Number	Supplement Number
K172644	000