SCS Freedom-8A Trial Neurostimulator Kit Channel A

GUDID 00850051034109

SCS Freedom-8A Trial Neurostimulator Kit Channel A

Curonix LLC

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

• Primary Device ID: 00850051034109
• NIH Device Record Key: e4cb2f8b-cba2-4583-aaf1-4f64f553ba2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCS Freedom-8A Trial Neurostimulator Kit Channel A
• Version Model Number: FR8A-TRL-A0
• Company DUNS: 118972620
• Company Name: Curonix LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850051034109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182720

FDA Product Code

• GZB: Stimulator, Spinal-Cord, Implanted (Pain Relief)

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: 2023-04-14
• Device Publish Date: 2023-04-06

Devices Manufactured by Curonix LLC

• 00850051034598 - Freedom System Accessories: 2023-12-13 13" Antenna w/Velcro - Large
• 00850051034604 - Freedom System Accessories: 2023-12-13 13" Antenna w/Snaps - Large
• 00850051034628 - Freedom System Accessories: 2023-12-13 20" Antenna w/Snaps - Large
• 00850051034642 - Freedom System Accessories: 2023-12-13 28" Antenna w/ Snaps - Large
• 00850051034673 - Freedom System Accessories: 2023-12-13 40" Antenna w/ Velcro - Large
• 00850051034697 - Freedom System Accessories: 2023-12-13 20" Antenna w/ Velcro - Large
• 00850051034710 - Freedom System Accessories: 2023-12-13 28" Antenna w/Velcro - Large
• 00850051034741 - Freedom System Accessories: 2023-12-13 40" Antenna w/ Velcro - Large