WaveWriter Alpha™ 16

GUDID 08714729985082

Implantable Pulse Generator Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Analgesic spinal cord electrical stimulation system pulse generator, implantable

• Primary Device ID: 08714729985082
• NIH Device Record Key: bb317a82-d773-453e-850c-905dac1fef62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaveWriter Alpha™ 16
• Version Model Number: SC-1216
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	08714729985082 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-05
• Device Publish Date: 2020-12-28

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)