Fixate™ Suturing Device FB-201-01

GUDID M365FB201010

Fixate™ Suturing Device

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system Analgesic spinal cord electrical stimulation system

• Primary Device ID: M365FB201010
• NIH Device Record Key: 8d583171-e61c-4412-b94f-fbc16b9db58f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixate™ Suturing Device
• Version Model Number: FB-201-01
• Catalog Number: FB-201-01
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• Device Count: 1
• 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: true
• Lot Batch: true
• Serial Number: false
• 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
HIBCC	M365FB201010 [Primary]

FDA Product Code

• GZB: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Sterilization

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

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

[M365FB201010]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2014-09-24

On-Brand Devices [Fixate™ Suturing Device]

• M365FB201010: Fixate™ Suturing Device
• M365FB101010: Fixate™ Suturing Device