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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
Polyolefin/fluoropolymer suture, multifilament FDA UDI
Device Name
Fixate™ Suturing Device FDA UDI
Model / Reference
SC-4317-01 FDA UDI
Description
Fixate™ Suturing Device FDA UDI

Identifiers

Catalog Number
SC-4317-01 FDA UDI
Primary DI / UDI-DI
M365FB101010 FDA UDI
FDA Product Code
GAT FDA UDI
GZB FDA UDI
GMDN Term
Polyolefin/fluoropolymer suture, multifilament FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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 d2e600b2-8a6e-498c-bd3c-a2d4ce7d6fc9 33 fields · synced Jun 6, 2026