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Fixate™ Suturing Device

FDA UDI

Class II (US FDA UDI)

by Boston Scientific Neuromodulation

Identity

Trade Name
Fixate™ Suturing Device FDA UDI
Generic Name
Analgesic spinal cord electrical stimulation system FDA UDI
Device Name
Fixate™ Suturing Device FDA UDI
Model / Reference
FB-201-01 FDA UDI
Description
Fixate™ Suturing Device FDA UDI

Identifiers

Catalog Number
FB-201-01 FDA UDI
Primary DI / UDI-DI
M365FB201010 FDA UDI
FDA Product Code
GZB FDA UDI
GAT FDA UDI
GMDN Term
Analgesic spinal cord electrical stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5880 FDA UDI
878.5000 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Polyolefin/fluoropolymer suture, multifilamentAnalgesic spinal cord electrical stimulation system

Fixate™ Suturing Device by Boston Scientific Neuromodulation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic spinal cord electrical stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific Neuromodulation

Sources (1)

  • FDA UDI 8d583171-e61c-4412-b94f-fbc16b9db58f 33 fields · synced Jun 6, 2026