OptiCross

GUDID 08714729842248

40 MHz Imaging Catheter

BOSTON SCIENTIFIC CORPORATION

Intravascular ultrasound imaging catheter, single-use
Primary Device ID08714729842248
NIH Device Record Keycfcec36d-ca3a-427c-89fc-7d7e72c4ab9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiCross
Version Model NumberH749518080
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 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729842248 [Primary]

FDA Product Code

OBJCatheter, ultrasound, intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-11
Device Publish Date2016-09-24

On-Brand Devices [OptiCross]

0871472989039340 MHz Coronary Imaging Catheter
0871472984787840 MHz Coronary Imaging Catheter
0871472984224840 MHz Imaging Catheter
0871472984153140 MHz Coronary Imaging Catheter

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