OPAL HDx™ M004OPAL40100

GUDID 00191506055301

Mapping System Workstation PC

BOSTON SCIENTIFIC CORPORATION

Cardiac mapping system
Primary Device ID00191506055301
NIH Device Record Key9312698e-d486-4d54-af59-2633d1fd4ee6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPAL HDx™
Version Model NumberM004OPAL40100
Catalog NumberM004OPAL40100
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100191506055301 [Primary]

FDA Product Code

DQKComputer, diagnostic, programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-16
Device Publish Date2024-10-08

On-Brand Devices [OPAL HDx™]

00191506055370Mapping System
00191506055325Mapping System Signal Station
00191506055301Mapping System Workstation PC

Trademark Results [OPAL HDx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPAL HDX
OPAL HDX
98509938 not registered Live/Pending
Boston Scientific Scimed, Inc.
2024-04-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.