GUDID 08714729991212

Clinician Programmer

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 08714729991212
• NIH Device Record Key: 03537ac3-a1de-4fcf-a7fa-d0a9767292dd
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: NM-7164
• 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	08714729991212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030017

FDA Product Code

• LGW: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• MHY: Stimulator, electrical, implanted, for parkinsonian tremor
• NHL: Stimulator, electrical, implanted, for parkinsonian symptoms

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-10
• Device Publish Date: 2020-01-31

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

• 08714729966333 - Vercise™ Cartesia™ X: 2024-12-23 Directional Lead Kit, 16 Contact, 30cm
• 08714729966340 - Vercise™ Cartesia™ X: 2024-12-23 Directional Lead Kit, 16 Contact, 45cm
• 08714729966357 - Vercise™ Cartesia™ HX: 2024-12-23 Directional Lead Kit, 16 Contact, 30cm
• 08714729966364 - Vercise™ Cartesia™ HX: 2024-12-23 Directional Lead Kit, 16 Contact, 45cm
• 08714729966371 - NA: 2024-12-23 Lead Extension Kit, 2x8 Contact, 55cm
• 08714729966388 - NA: 2024-12-23 Lead Extension Kit, 2x8 Contact, 95cm
• 08714729966395 - NA: 2024-12-23 16 Contact Lead Extension Kit, 55 cm
• 08714729966401 - NA: 2024-12-23 16 Contact Lead Extension Kit, 95 cm