Prelude IDeal™ Hydrophilic Sheath K21-00046

GUDID 20884450474062

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable
Primary Device ID20884450474062
NIH Device Record Key8563179f-c38b-43bc-a4e3-5355d9fc55b6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrelude IDeal™ Hydrophilic Sheath
Version Model Number00884450474068
Catalog NumberK21-00046
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100884450474068 [Primary]
GS110884450474065 [Package]
Contains: 00884450474068
Package: [5 Units]
In Commercial Distribution
GS120884450474062 [Package]
Contains: 10884450474065
Package: [4 Units]
In Commercial Distribution

FDA Product Code

OEXCardiovascular catheter sheath introducer kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-27
Device Publish Date2020-02-19

On-Brand Devices [Prelude IDeal™ Hydrophilic Sheath]

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1088445040698100884450406984
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1088445046532200884450465325
2088445047408600884450474082
2088445047407900884450474075
2088445047406200884450474068
1088445047691500884450476918
1088445047690800884450476901
2088445046542800884450465424
2088445048294400884450482940
1088445048295400884450482957
1088445048267100884450482674
2088445048068110884450480684
1088445048528300884450485286
1088445049316500884450493168
2088445053276200884450532768
2088445052703400884450527030
1088445053070900884450530702
1088445048714000884450487143
1088445053279600884450532799
2088445047409300884450474099

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