Prelude IDeal™ Hydrophilic Sheath K21-00037

GUDID 20884450443679

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable
Primary Device ID20884450443679
NIH Device Record Key148242e9-224b-40b3-bec2-4140a9d6a5c0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrelude IDeal™ Hydrophilic Sheath
Version Model Number00884450443675
Catalog NumberK21-00037
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
GS100884450443675 [Primary]
GS110884450443672 [Package]
Contains: 00884450443675
Package: [5 Units]
In Commercial Distribution
GS120884450443679 [Package]
Contains: 10884450443672
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 Date2019-11-27
Device Publish Date2019-11-19

On-Brand Devices [Prelude IDeal™ Hydrophilic Sheath]

1088445040104700884450401040
2088445042635100884450426357
1088445042633000884450426333
1088445040698100884450406984
2088445044366210884450443665
2088445044367900884450443675

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