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Evolution

FDA UDI

Class II (US FDA UDI)

by Cook Ireland, Ltd.

Identity

Trade Name
Evolution FDA UDI
Generic Name
Polymer-metal oesophageal stent FDA UDI
Device Name
EVOLUTION ESOPHAGEAL, STENT SYSTEM - PARTIALLY COVERED FDA UDI
Model / Reference
G48030 FDA UDI
Description
EVOLUTION ESOPHAGEAL, STENT SYSTEM - PARTIALLY COVERED FDA UDI

Identifiers

Catalog Number
EVO-20-25-8-E FDA UDI
Primary DI / UDI-DI
10827002480305 FDA UDI
FDA Product Code
ESW FDA UDI
GMDN Term
Polymer-metal oesophageal stent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3610 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Polymer-metal oesophageal stent

Evolution by Cook Ireland, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymer-metal oesophageal stent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cook Ireland, Ltd.

Sources (1)

  • FDA UDI ac36980b-f567-434a-be3a-b7f260471c17 36 fields · synced May 30, 2026