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AdvanTrode

FDA UDI

Class II (US FDA UDI)

by Pepin Manufacturing, Inc.

Identity

Trade Name
AdvanTrode FDA UDI
Generic Name
Transcutaneous electrical stimulation electrode, single-use FDA UDI
Device Name
3" x 5" (7.5cm x 13cm) Rectangle FDA UDI
Model / Reference
WWS35 FDA UDI
Description
3" x 5" (7.5cm x 13cm) Rectangle FDA UDI

Identifiers

Primary DI / UDI-DI
00677346310393 FDA UDI
510(k) Number
K070807 FDA UDI
FDA Product Code
GXY FDA UDI
GMDN Term
Transcutaneous electrical stimulation electrode, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1320 FDA UDI
Commercial Distribution
Not 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

AdvanTrode by Pepin Manufacturing, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K070807 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pepin Manufacturing, Inc.

Sources (1)

  • FDA UDI 0d383a19-5f8f-4b0b-8df9-36c2188d99b9 35 fields · synced May 30, 2026