WaveWriter Alpha™ Prime 16

GUDID 08714729985068

Implantable Pulse Generator Kit

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Analgesic spinal cord electrical stimulation system pulse generator, implantable

• Primary Device ID: 08714729985068
• NIH Device Record Key: 5c66d0c7-8aea-46d0-8efa-8501a9642688
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaveWriter Alpha™ Prime 16
• Version Model Number: SC-1416
• 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	08714729985068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030017

FDA Product Code

• LGW: Stimulator, spinal-cord, totally implanted for pain relief
• QRB: Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

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

• 08714729950684 - Entrada ™: 2025-08-25 Needle 11cm (4.5in)
• 08714729950691 - Entrada ™: 2025-08-25 Needle 15cm (6.0 in)
• 08714729950707 - Entrada ™: 2025-08-25 Spare Sheath 11cm (4.5 in)
• 08714729950714 - Entrada ™: 2025-08-25 Spare Sheath 15cm (6.0 in)
• 08714729952053 - Freelink™: 2025-08-25 Remote Control
• 08714729953449 - Freelink™: 2025-08-25 Remote Control Kit
• 08714729953487 - Bionic Navigator™ 3D: 2025-08-25 BN 3D 2.0 Installer
• 08714729820758 - Vercise™: 2025-08-12 Implantable Pulse Generator Kit