Prelude IDeal™ Hydrophilic Sheath K21-00036A

GUDID 20884450480681

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable
Primary Device ID20884450480681
NIH Device Record Key31330b6f-0735-48e5-a6b8-9715d2dcb694
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrelude IDeal™ Hydrophilic Sheath
Version Model Number10884450480684
Catalog NumberK21-00036A
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
Device Count5
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
GS100884450480687 [Unit of Use]
GS100884450480687 [Unit of Use]
GS100884450480687 [Unit of Use]
GS100884450480687 [Unit of Use]
GS110884450480684 [Primary]
GS110884450480684 [Primary]
GS110884450480684 [Primary]
GS110884450480684 [Primary]
GS120884450480681 [Package]
Contains: 10884450480684
Package: [4 Units]
In Commercial Distribution
GS120884450480681 [Package]
Contains: 10884450480684
Package: [4 Units]
In Commercial Distribution
GS120884450480681 [Package]
Contains: 10884450480684
Package: [4 Units]
In Commercial Distribution
GS120884450480681 [Package]
Contains: 10884450480684
Package: [4 Units]
In Commercial Distribution

FDA Product Code

OEXCardiovascular catheter sheath introducer kit
OEXCardiovascular catheter sheath introducer kit
OEXCardiovascular catheter sheath introducer kit
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 Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [Prelude IDeal™ Hydrophilic Sheath]

1088445040104700884450401040
2088445042635100884450426357
1088445042633000884450426333
1088445040698100884450406984
2088445044366210884450443665
2088445044367900884450443675
1088445046532200884450465325
2088445047408600884450474082
2088445047407900884450474075
2088445047406200884450474068
1088445047691500884450476918
1088445047690800884450476901
2088445046542800884450465424
2088445048294400884450482940
1088445048295400884450482957
1088445048267100884450482674
2088445048068110884450480684

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