Prelude EASE™ PHR6F11018SC/F

GUDID 20884450526112

Merit Medical Systems, Inc.

Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use
Primary Device ID20884450526112
NIH Device Record Keydb7ae82c-08f9-4cef-8da8-2d992f818b20
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrelude EASE™
Version Model Number10884450526115
Catalog NumberPHR6F11018SC/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 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

Device Dimensions

Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS100884450526118 [Unit of Use]
GS110884450526115 [Primary]
GS120884450526112 [Package]
Contains: 10884450526115
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [Prelude EASE™]

2088445025793110884450257934
2088445025792410884450257927
2088445033382610884450333829
2088445028921510884450289218
2088445052614310884450526146
2088445052615010884450526153
2088445052598610884450525989
2088445052556610884450525569
2088445052618110884450526184
2088445052610510884450526108
2088445052611210884450526115
2088445052551110884450525514

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