Prelude PRO™ PRO-6F-11-038-18G/C

GUDID 20884450330405

Merit Medical Systems, Inc.

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Primary Device ID20884450330405
NIH Device Record Key480b5b1b-949a-45aa-9335-0168813a17bb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrelude PRO™
Version Model Number10884450330408
Catalog NumberPRO-6F-11-038-18G/C
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS100884450330401 [Unit of Use]
GS110884450330408 [Primary]
GS120884450330405 [Package]
Contains: 10884450330408
Package: [4 Units]
In Commercial Distribution

FDA Product Code

DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-01
Device Publish Date2021-11-23

On-Brand Devices [Prelude PRO™]

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