Prelude EASE™ PHR7F11018SC/F

GUDID 20884450526341

Merit Medical Systems, Inc.

Vascular dilator, single-use
Primary Device ID20884450526341
NIH Device Record Key1ef81a82-1403-4bb8-9e10-a9c82b8410a4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrelude EASE™
Version Model Number10884450526344
Catalog NumberPHR7F11018SC/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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100884450526347 [Unit of Use]
GS110884450526344 [Primary]
GS120884450526341 [Package]
Contains: 10884450526344
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 Date2021-08-02
Device Publish Date2021-07-23

On-Brand Devices [Prelude EASE™]

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2088445025792410884450257927
2088445033382610884450333829
2088445028921510884450289218
2088445052614310884450526146
2088445052615010884450526153
2088445052598610884450525989
2088445052556610884450525569
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2088445052610510884450526108
2088445052611210884450526115
2088445052551110884450525514
2088445052597910884450525972
2088445052460610884450524609
2088445052600610884450526009
2088445052629710884450526290
2088445052632710884450526320
2088445052599310884450525996
2088445052619810884450526191
2088445052616710884450526160
2088445052638910884450526382
2088445052433010884450524333
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2088445052622810884450526221
2088445033381910884450333812
2088445033379610884450333799
2088445030652310884450306526
2088445030637010884450306373
2088445030632510884450306328
2088445029002010884450290023
2088445028950510884450289508
2088445028949910884450289492
2088445028948210884450289485
2088445028947510884450289478
2088445028946810884450289461
2088445028945110884450289454
2088445028944410884450289447
2088445028943710884450289430
2088445028942010884450289423
2088445028941310884450289416
2088445028940610884450289409
2088445028939010884450289393
2088445028938310884450289386
2088445028937610884450289379
2088445028936910884450289362
2088445028935210884450289355
2088445028934510884450289348
2088445028933810884450289331
2088445028932110884450289324

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