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Echelon Flex

FDA UDI

Class II (US FDA UDI)

by Ethicon Endo-Surgery, Inc.

Identity

Trade Name
ECHELON FLEX FDA UDI
Generic Name
Endoscopic motorized cutting stapler, single-use FDA UDI
Device Name
ECHELON FLEX POWERED PLUS COMPACT ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM FDA UDI
Model / Reference
PCEE60A FDA UDI
Description
ECHELON FLEX POWERED PLUS COMPACT ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM FDA UDI

Identifiers

Catalog Number
PCEE60A FDA UDI
Primary DI / UDI-DI
10705036015017 FDA UDI
FDA Product Code
GDW FDA UDI
GMDN Term
Endoscopic motorized cutting stapler, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4750 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endoscopic motorized cutting stapler, single-use

Echelon Flex by Ethicon Endo-Surgery, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic motorized cutting stapler, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ethicon Endo-Surgery, Inc.

Sources (1)

  • FDA UDI cc00d22d-7685-47d8-bf58-8080bc07dd0c 36 fields · synced May 30, 2026