Peripheral RotaLink® Plus

GUDID 08714729838951

Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device

BOSTON SCIENTIFIC CORPORATION

Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered
Primary Device ID08714729838951
NIH Device Record Keyce6f1960-5560-47cc-83c7-7631fca86064
Commercial Distribution StatusIn Commercial Distribution
Brand NamePeripheral RotaLink® Plus
Version Model NumberM0011402380
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS108714729838951 [Primary]

FDA Product Code

MCWCatheter, peripheral, atherectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-06
Device Publish Date2016-09-24

On-Brand Devices [Peripheral RotaLink® Plus]

08714729857808Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729838968Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729838951Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729838944Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729838937Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729838920Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729838913Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729838906Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device

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