Sparrow Ascent Cable

GUDID 00860005396979

The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece. The Cable length is designed to allow the user to carry the Patient Controller in a pocket or worn in the Belt Clip(model 610) without constricting mobility. A built-in retention clip allows the user to clip the Cable to their clothing to relieve cable strain. This is a subcomponent and is not transacted. See 810-P.

Spark Biomedical Inc.

Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator

• Primary Device ID: 00860005396979
• NIH Device Record Key: f7b5b453-35fc-4069-b2b1-86e922bb179b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sparrow Ascent Cable
• Version Model Number: 810
• Company DUNS: 074715155
• Company Name: Spark Biomedical Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00860005396979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230796

FDA Product Code

• PZR: Percutaneous Nerve Stimulator For Opioid Withdrawal

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: 2023-09-15
• Device Publish Date: 2023-09-07

On-Brand Devices [Sparrow Ascent Cable]

• 00860005396979: The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece.
• 00850052017040: The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece.