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L300 Go System

FDA UDI

Class II (US FDA UDI)

by Bioness Inc.

Identity

Trade Name
L300 Go System FDA UDI
Generic Name
Transcutaneous electrical stimulation electrode, reusable FDA UDI
Device Name
Small Quick Fit Electrodes - B FDA UDI
Model / Reference
LG3-6900 FDA UDI
Description
Small Quick Fit Electrodes - B FDA UDI

Identifiers

Primary DI / UDI-DI
00815962020504 FDA UDI
FDA Product Code
GZI FDA UDI
IPF FDA UDI
GMDN Term
Transcutaneous electrical stimulation electrode, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5810 FDA UDI
890.5850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Transcutaneous electrical stimulation electrode, reusable

L300 Go System by Bioness Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcutaneous electrical stimulation electrode, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioness Inc.

Sources (1)

  • FDA UDI 448170a7-4dfc-459c-852e-85056910bd2d 34 fields · synced Jun 6, 2026