Fixate™ Suturing Device FB-201-01

GUDID M365FB201010

Fixate™ Suturing Device

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

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