Precision ™ SC-4500

GUDID 08714729121770

IR Interface

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

• Primary Device ID: 08714729121770
• NIH Device Record Key: 587fd601-f431-490b-82ff-d55126c63b7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision ™
• Version Model Number: SC-4500
• Catalog Number: SC-4500
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729121770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030017

FDA Product Code

• LGW: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-03-13
• Device Publish Date: 2015-08-20

On-Brand Devices [Precision ™]

• 08714729121770: IR Interface
• 08714729121756: Patient Controller
• 08714729821632: Patient Trial Kit
• 08714729767565: External Trial Stimulator
• 08714729121657: Base Station
• 08714729121428: Lead Blank
• 08714729837343: Clinician Programmer Refurbished
• 08714729837336: Clinician Programmer Refurbished
• 08714729837282: Remote Control (Refurbished)
• 08714729837244: External Trial Stimulator (Refurbished)
• 08714729784760: Remote Control
• 08714729121688: Adhesive Kit