Freedom System Accessories

GUDID 00850051034505

Torso Wearable XL

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: 00850051034505
• NIH Device Record Key: 081319d1-ca48-4fa6-90a4-f3f289d30638
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freedom System Accessories
• Version Model Number: 00-52016
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850051034505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182720

FDA Product Code

• GZF: Stimulator, Peripheral Nerve, 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

On-Brand Devices [Freedom System Accessories]

• 00850051034550: Transmitter Assembly (915MHz)
• 00850051034543: Torso Wearable S
• 00850051034529: Torso Wearable L
• 00850051034512: Torso Wearable XXL
• 00850051034505: Torso Wearable XL
• 00850051034499: Torso Wearable XS
• 00850051034215: FR Stylet
• 00850051034208: PNS Wearable Accessory S/M
• 00850051034192: PNS Wearable Accessory L/XL Vertical
• 00850051034277: Sterile Revision Kit
• 00850051034260: Antenna 27" Length
• 00850051034253: Antenna 12" Length
• 00850051034178: 6" Introducer
• 00850051034161: Guidewire 3-Pack
• 00850051034154: 13G Tuohy Needle 4.5"
• 00850051034147: 13G Tuohy Needle 6"
• 00850051034888: 8" Antenna w/ Snaps - Small
• 00850051034864: 42" Antenna w/ Velcro - Small
• 00850051034840: 18" Antenna w/ Velcro - Small
• 00850051034826: 12" Antenna w/ Velcro - Small
• 00850051034819: 8" Antenna w/ Velcro - Small
• 00850051034796: 42" Antenna w/ Snaps - Small
• 00850051034772: 18" Antenna w/ Snaps - Small
• 00850051034758: 12" Antenna w/ Snaps - Small
• 00850051034741: 40" Antenna w/ Velcro - Large
• 00850051034710: 28" Antenna w/Velcro - Large
• 00850051034697: 20" Antenna w/ Velcro - Large
• 00850051034673: 40" Antenna w/ Velcro - Large
• 00850051034642: 28" Antenna w/ Snaps - Large
• 00850051034628: 20" Antenna w/Snaps - Large
• 00850051034604: 13" Antenna w/Snaps - Large
• 00850051034598: 13" Antenna w/Velcro - Large