GUDID 08714729935063

Clinician Programmer (Refurbished)

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Deep brain electrical stimulation system

• Primary Device ID: 08714729935063
• NIH Device Record Key: 040ebd2b-bc8e-4575-98b1-4b4447f5bfe9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: NM-7161R
• 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	08714729935063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030017

FDA Product Code

• PJS: Stimulator, electrical, implanted, for essential tremor

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: 2021-11-24
• Device Publish Date: 2017-04-14

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

• 08714729888734 - Precision™: 2024-09-24 M8 Adapter, 15cm
• 08714729888758 - Precision™: 2024-09-24 M8 Adapter, 55cm
• 08714729893271 - Precision™: 2024-09-24 S8 Adapter, 15cm
• 08714729893288 - Precision™: 2024-09-24 S8 Adapter, 55cm
• 08714729897804 - NA: 2024-08-21 Installer for BN3.1
• 08714729897811 - NA: 2024-08-21 Clinician Programmer
• 08714729897835 - Precision Novi™: 2024-08-21 Implantable Pulse Generator Kit
• 08714729897873 - NA: 2024-08-21 Clinican Programmer (Refurbished)