OptiCross X

GUDID 08714729893264

Coronary Imaging Catheter

BOSTON SCIENTIFIC CORPORATION

Intravascular ultrasound imaging catheter, single-use
Primary Device ID08714729893264
NIH Device Record Key210de819-6266-4fdb-b365-2b6ddfd3946f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiCross X
Version Model NumberH74939405030
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
GS108714729893264 [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

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

00802526610202 - LATITUDE™ Programming System2020-02-17 LATITUDE ™ Programming System
00802526604577 - INGEVITY™+2020-02-14 Endocardial, Steroid-eluting, Polyurethane, IROX™-coated Electrodes, MR Conditional, Stylet delivered
00802526604522 - INGEVITY™+2020-02-14 Endocardial, Steroid-eluting, Polyurethane, IROX™-coated Electrodes, MR Conditional, Stylet delivered
00802526604430 - INGEVITY™+2020-02-14 Endocardial, Steroid-eluting, Polyurethane, IROX™-coated Electrodes, MR Conditional, Stylet delivered
08714729283997 - Rotatable Snare2020-02-13 Single-Use Polypectomy Snare
08714729283980 - Rotatable Snare2020-02-13 Single-Use Polypectomy Snare
08714729719120 - RIGIFLEX II2020-02-13 Single Use Achalasia Ballon Dilator
08714729719113 - RIGIFLEX II2020-02-13 Single Use Achalasia Ballon Dilator

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