Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: Medline FDA UDI
Generic Name: Electrosurgical handpiece, single-use FDA UDI
Device Name: DBD-PENCIL,CAUTERY,ROCKER,STERILE,LF,SS FDA UDI
Model / Reference: ESRK3000V FDA UDI
Description: DBD-PENCIL,CAUTERY,ROCKER,STERILE,LF,SS FDA UDI

Identifiers

Catalog Number: ESRK3000V FDA UDI
Primary DI / UDI-DI: 10884389161135 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Electrosurgical handpiece, 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

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrosurgical handpiece, single-use

Medline by Medline Industries, 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: Medline Industries, Inc.

Sources (1)

FDA UDI 17ccf16b-d2d6-41c3-9cc6-847ec517b323 35 fields · synced Jun 1, 2026