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Elation 5™

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Elation 5™ FDA UDI
Generic Name
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Model / Reference
00884450487129 FDA UDI

Identifiers

Catalog Number
EPX18 FDA UDI
Primary DI / UDI-DI
00884450487129 FDA UDI
FDA Product Code
KNQ FDA UDI
GMDN Term
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5365 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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Gastrointestinal/biliary dilation balloon catheter, non-medicated

Introducing the Elation 5, a cutting-edge gastrointestinal/biliary dilation balloon catheter designed for precise and effective treatment of strictures in the oesophagus, pylorus, colon, and/or biliary tract. With its patented inflatable balloon technology and non-medicated design, this single-use device is ideal for clinicians seeking to improve patient outcomes.

Similar devices

Also classified as Gastrointestinal/biliary dilation balloon catheter, non-medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI 85cc5be0-b4c9-41c3-bbe6-2642b956142d 34 fields · synced Oct 6, 2026