Freedom System Accessory

GUDID 00850051034536

Torso Wearable M

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: 00850051034536
• NIH Device Record Key: 9989098c-5788-49a7-bc0f-afa3ebbe0cc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freedom System Accessory
• Version Model Number: 00-52014
• Company DUNS: 118972620
• Company Name: Curonix LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850051034536 [Primary]

FDA Product Code

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

Sterilization

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

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