Epimed

FDA UDI

Class II (US FDA UDI)

by Epimed International, Inc.

Identity

Trade Name: Epimed FDA UDI
Generic Name: Electrosurgical return electrode, single-use FDA UDI
Device Name: PainBlocker™ 4.5" x 7" Grounding Pad FDA UDI
Model / Reference: 420-PBGP FDA UDI
Description: PainBlocker™ 4.5" x 7" Grounding Pad FDA UDI

Identifiers

Catalog Number: 420-PBGP FDA UDI
Primary DI / UDI-DI: 00818788020550 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Electrosurgical return electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Width — 4.5 Inch FDA UDI
Length — 7 Inch FDA UDI

Category: Electrosurgical return electrode, single-use

Epimed by Epimed International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Epimed International, Inc.

Sources (1)

FDA UDI ecceb9d0-c41b-428a-809b-ddf339f99915 37 fields · synced Jun 4, 2026