DiamondTOUCH™ IN9152/A

GUDID 10884450409654

Merit Medical Systems, Inc.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use
Primary Device ID10884450409654
NIH Device Record Keyed1838c7-c266-4356-8a61-8939854de665
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiamondTOUCH™
Version Model Number00884450409657
Catalog NumberIN9152/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 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
GS100884450409657 [Primary]
GS100884450409657 [Primary]
GS100884450409657 [Primary]
GS100884450409657 [Primary]
GS110884450409654 [Package]
Contains: 00884450409657
Package: [5 Units]
In Commercial Distribution
GS110884450409654 [Package]
Contains: 00884450409657
Package: [5 Units]
In Commercial Distribution
GS110884450409654 [Package]
Contains: 00884450409657
Package: [5 Units]
In Commercial Distribution
GS110884450409654 [Package]
Contains: 00884450409657
Package: [5 Units]
In Commercial Distribution
GS120884450409651 [Package]
Package: [2 Units]
In Commercial Distribution
GS120884450409651 [Package]
Package: [2 Units]
In Commercial Distribution
GS120884450409651 [Package]
Package: [2 Units]
In Commercial Distribution
GS120884450409651 [Package]
Package: [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXTInjector and syringe, angiographic
DXTInjector and syringe, angiographic
DXTInjector and syringe, angiographic
DXTInjector and syringe, angiographic

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 [DiamondTOUCH™]

1088445032481000884450324813
2088445032480000884450324806
1088445032478000884450324783
2088445026490800884450264904
2088445041346700884450413463
1088445040965400884450409657

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