COBLATOR II Flow Valve

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: COBLATOR II Flow Valve FDA UDI
Generic Name: Electrosurgical system generator FDA UDI
Device Name: COBLATOR II FLOW CONTROL UNIT FDA UDI
Model / Reference: EA8002-00 FDA UDI
Description: COBLATOR II FLOW CONTROL UNIT FDA UDI

Identifiers

Catalog Number: EA8002-00 FDA UDI
Primary DI / UDI-DI: 00817470002157 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Electrosurgical system generator 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrosurgical system generator

COBLATOR II Flow Valve by Smith & Nephew, 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: Smith & Nephew, Inc.

Sources (1)

FDA UDI 23b00d89-2504-43ff-8ba0-ea700fe1816f 35 fields · synced Jun 8, 2026