Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: Medline FDA UDI
Generic Name: Electrosurgical system generator FDA UDI
Device Name: SHROUD, ATTACHMENT, SMOKE EVAC, 10' FDA UDI
Model / Reference: ESSHROUD10 FDA UDI
Description: SHROUD, ATTACHMENT, SMOKE EVAC, 10' FDA UDI

Identifiers

Catalog Number: ESSHROUD10 FDA UDI
Primary DI / UDI-DI: 10193489085358 FDA UDI
FDA Product Code: FYD FDA UDI
GMDN Term: Electrosurgical system generator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5070 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrosurgical system generator

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 fdc679ae-1a81-42db-898c-503e47170ad6 36 fields · synced May 30, 2026