PN Wearable Accessory L/XL Horizontal

GUDID 00850051034185

PNS Wearable Accessory L/XL Horizontal

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: 00850051034185
• NIH Device Record Key: 38417024-469f-4341-bf7b-646ba6cb8b72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PN Wearable Accessory L/XL Horizontal
• Version Model Number: 00-52003
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850051034185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152178

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

Devices Manufactured by Curonix LLC

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• 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