Precision Spectra™

GUDID 08714729821595

Remote Control Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system control unit

• Primary Device ID: 08714729821595
• NIH Device Record Key: aac072b4-139e-4e8b-ac2e-fe47bc0e6456
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision Spectra™
• Version Model Number: SC-5532-1
• 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: true
• 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	08714729821595 [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: 2024-08-20
• Device Publish Date: 2015-12-14

On-Brand Devices [Precision Spectra™]

• 08714729861539: Implantable Pulse Generator and Charging Kit
• 08714729821595: Remote Control Kit