Hydrophilic Prelude SNAP™ PLSH-1007/A

GUDID 00884450495056

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
Primary Device ID00884450495056
NIH Device Record Keyb1e74397-7169-4d3a-b089-94cd9a74c909
Commercial Distribution StatusIn Commercial Distribution
Brand NameHydrophilic Prelude SNAP™
Version Model Number10884450495053
Catalog NumberPLSH-1007/A
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 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
GS100884450495056 [Unit of Use]
GS100884450495056 [Unit of Use]
GS100884450495056 [Unit of Use]
GS100884450495056 [Unit of Use]
GS100884450495056 [Unit of Use]
GS100884450495056 [Unit of Use]
GS100884450495056 [Unit of Use]
GS100884450495056 [Unit of Use]
GS110884450495053 [Primary]
GS110884450495053 [Primary]
GS110884450495053 [Primary]
GS110884450495053 [Primary]
GS110884450495053 [Primary]
GS110884450495053 [Primary]
GS110884450495053 [Primary]
GS110884450495053 [Primary]

FDA Product Code

DYBINTRODUCER, CATHETER
DYBINTRODUCER, CATHETER
DYBINTRODUCER, CATHETER
DYBINTRODUCER, CATHETER
DYBINTRODUCER, CATHETER
DYBINTRODUCER, CATHETER
DYBINTRODUCER, CATHETER
DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [Hydrophilic Prelude SNAP™]

0088445049505610884450495053
0088445049504910884450495046

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.