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Prelude EASE™

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Prelude EASE™ FDA UDI
Generic Name
Vascular dilator, single-use FDA UDI
Model / Reference
10884450526290 FDA UDI

Identifiers

Catalog Number
PHR6F23021SC/F FDA UDI
Primary DI / UDI-DI
10884450526290 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Vascular dilator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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

Yes

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

Category: Vascular dilator, single-use

Prelude EASE is a versatile, single-use vascular dilator designed for precise blood vessel manipulation during surgical procedures. Featuring a durable design and advanced features, this device provides accurate placement and measurement of internal vessel diameters. With its user-friendly interface and easy-to-follow instructions, Prelude EASE facilitates seamless clinical outcomes.

Similar devices

Also classified as Vascular dilator, single-use.

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 cc9fe0ae-d9a9-4c8a-ac5c-233f25ed6a67 34 fields · synced Jul 13, 2026