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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
10884450008857 FDA UDI

Identifiers

Primary DI / UDI-DI
10884450008857 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

Prelude is a sterile, hand-held surgical instrument designed for insertion into blood vessels to unblock, enlarge or measure their internal diameter during a surgical intervention. A rod-like device with a long body and bulbous distal tip, available in various sizes and flexibilities.

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 a794ba74-0a72-49c8-943a-35f05d952003 33 fields · synced Jul 3, 2026