Advocate™ A18050150090/A

GUDID 10884450305307

Merit Medical Systems, Inc.

Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic
Primary Device ID10884450305307
NIH Device Record Key7ba71340-2048-489e-9ebf-31927b90826a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvocate™
Version Model Number00884450305300
Catalog NumberA18050150090/A
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS100884450305300 [Primary]
GS100884450305300 [Primary]
GS100884450305300 [Primary]
GS100884450305300 [Primary]
GS100884450305300 [Primary]
GS100884450305300 [Primary]
GS100884450305300 [Primary]
GS100884450305300 [Primary]
GS100884450305300 [Primary]
GS100884450305300 [Primary]
GS100884450305300 [Primary]
GS100884450305300 [Primary]
GS100884450305300 [Primary]
GS100884450305300 [Primary]
GS100884450305300 [Primary]
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution
GS110884450305307 [Package]
Contains: 00884450305300
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal
LITCatheter, angioplasty, peripheral, transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

On-Brand Devices [Advocate™]

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1088445030531400884450305317
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1088445030329700884450303290
1088445030302000884450303023
1088445030045600884450300459
1088445030035700884450300350

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