NC Quantum Apex™

GUDID 08714729785743

PTCA Dilatation Catheter

BOSTON SCIENTIFIC CORPORATION

Coronary angioplasty balloon catheter, basic
Primary Device ID08714729785743
NIH Device Record Keyf363f1a1-4031-44a0-aa6b-7229792946c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNC Quantum Apex™
Version Model NumberH7493912512370
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 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
GS108714729785743 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOXCatheters, transluminal coronary angioplasty, percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2016-09-24

On-Brand Devices [NC Quantum Apex™]

08714729786085PTCA Dilatation Catheter
08714729786078PTCA Dilatation Catheter
08714729786061PTCA Dilatation Catheter
08714729786054PTCA Dilatation Catheter
08714729786047PTCA Dilatation Catheter
08714729786030PTCA Dilatation Catheter
08714729786023PTCA Dilatation Catheter
08714729786016PTCA Dilatation Catheter
08714729786009PTCA Dilatation Catheter
08714729785996PTCA Dilatation Catheter
08714729785989PTCA Dilatation Catheter
08714729785972PTCA Dilatation Catheter
08714729785965PTCA Dilatation Catheter
08714729785958PTCA Dilatation Catheter
08714729785941PTCA Dilatation Catheter
08714729785934PTCA Dilatation Catheter
08714729785927PTCA Dilatation Catheter
08714729785910PTCA Dilatation Catheter
08714729785903PTCA Dilatation Catheter
08714729785897PTCA Dilatation Catheter
08714729785880PTCA Dilatation Catheter
08714729785873PTCA Dilatation Catheter
08714729785866PTCA Dilatation Catheter
08714729785859PTCA Dilatation Catheter
08714729785842PTCA Dilatation Catheter
08714729785835PTCA Dilatation Catheter
08714729785828PTCA Dilatation Catheter
08714729785811PTCA Dilatation Catheter
08714729785804PTCA Dilatation Catheter
08714729785798PTCA Dilatation Catheter
08714729785781PTCA Dilatation Catheter
08714729785774PTCA Dilatation Catheter
08714729785767PTCA Dilatation Catheter
08714729785750PTCA Dilatation Catheter
08714729785743PTCA Dilatation Catheter
08714729785736PTCA Dilatation Catheter
08714729785729PTCA Dilatation Catheter
08714729785712PTCA Dilatation Catheter
08714729785705PTCA Dilatation Catheter
08714729785699PTCA Dilatation Catheter
08714729785682PTCA Dilatation Catheter
08714729785675PTCA Dilatation Catheter
08714729785668PTCA Dilatation Catheter
08714729785651PTCA Dilatation Catheter
08714729785644PTCA Dilatation Catheter
08714729785637PTCA Dilatation Catheter
08714729785620PTCA Dilatation Catheter
08714729785613PTCA Dilatation Catheter
08714729785606PTCA Dilatation Catheter
08714729785590PTCA Dilatation Catheter

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