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Prelude®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Prelude® FDA UDI
Generic Name
Vascular dilator, single-use FDA UDI
Model / Reference
10884450050726 FDA UDI

Identifiers

Primary DI / UDI-DI
10884450050726 FDA UDI
FDA Product Code
DRE FDA UDI
GMDN Term
Vascular dilator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1310 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

No

FDA UDI

Category: Vascular dilator, single-use

The Prelude device is a versatile, single-use vascular dilator designed for safe and effective insertion into blood vessels during surgical procedures. With a wide range of sizes (0.035" to 6F) and lengths (11 cm to 4.3 inches), it can be used for various applications, including peripheral angioplasty, coronary interventions, and more.

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 924c200f-06c2-4af7-b02c-7b5e9a2cc233 33 fields · synced Jul 19, 2026