Prelude Prestige™ PLPS-1005/A

GUDID 00884450510582

Merit Medical Systems, Inc.

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Primary Device ID00884450510582
NIH Device Record Key02ea2656-76d8-48f9-9663-9cb6f76b94d2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrelude Prestige™
Version Model Number10884450510589
Catalog NumberPLPS-1005/A
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
Device Count10
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 Datefalse
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
GS100884450510582 [Unit of Use]
GS110884450510589 [Primary]

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 Date2021-12-08
Device Publish Date2021-11-30

On-Brand Devices [Prelude Prestige™]

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0088445051029210884450510299
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0088445051052010884450510527
0088445051068110884450510688
0088445051032210884450510329
00884450510209A
0088445051027810884450510275

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