Prelude Wave™ WAV7F23021SSC-F

GUDID 20884450076181

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable
Primary Device ID20884450076181
NIH Device Record Key6807e81a-c394-47e7-a78e-22f7a76b61f2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrelude Wave™
Version Model NumberInitial Release
Catalog NumberWAV7F23021SSC-F
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS100884450076187 [Unit of Use]
GS110884450076184 [Primary]
GS120884450076181 [Package]
Contains: 10884450076184
Package: [4 Units]
In Commercial Distribution

FDA Product Code

DYBIntroducer, catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-14
Device Publish Date2025-08-06

On-Brand Devices [Prelude Wave™]

20884450072206Initial Release
20884450071131Initial Release
20884450068872Initial Release
20884450065444Initial Release
20884450073760Initial Release
20884450065383Initial Release
20884450076181Initial Release
20884450071117Initial Release
20884450065369Initial Release

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