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Pathway®

FDA UDI

Class II (US FDA UDI)

by Prometheus Group Of New Hampshire Limited, The

Identity

Trade Name
Pathway® FDA UDI
Generic Name
Perineal orifice incontinence-control electrical stimulation system probe, single-use FDA UDI
Device Name
Pathway® 6340 Rectal EMG/Stimulation Sensor FDA UDI
Model / Reference
6340 FDA UDI
Description
Pathway® 6340 Rectal EMG/Stimulation Sensor FDA UDI

Identifiers

Catalog Number
6340 FDA UDI
Primary DI / UDI-DI
00852423006189 FDA UDI
FDA Product Code
KPI FDA UDI
GMDN Term
Perineal orifice incontinence-control electrical stimulation system probe, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5320 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

Yes

FDA UDI

Category: PerineometerPerineal orifice incontinence-control electrical stimulation system probe, single-use

Pathway® by Prometheus Group Of New Hampshire Limited, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Perineal orifice incontinence-control electrical stimulation system probe, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Prometheus Group Of New Hampshire Limited, The

Sources (1)

  • FDA UDI b523e5d1-fd2f-4717-963a-195478c7458b 35 fields · synced May 30, 2026