RotaLink™ Advancer H80222782001A0

GUDID 08714729317739

Catheter 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
Primary Device ID08714729317739
NIH Device Record Key941a19d8-3734-4a8e-b36c-6362193364e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameRotaLink™ Advancer
Version Model NumberH80222782001A0
Catalog NumberH80222782001A0
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 Identifiers

Device Issuing AgencyDevice ID
GS108714729317739 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCXCATHETER, CORONARY, ATHERECTOMY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-05-04
Device Publish Date2014-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

08714729317739 - RotaLink™ Advancer2021-05-04Catheter Advancing Device
08714729317739 - RotaLink™ Advancer2021-05-04 Catheter Advancing Device
08714729414995 - Zero Tip2021-04-07 Airway Retrieval Basket
08714729415008 - Zero Tip2021-04-07 Airway Retrieval Basket
08714729784623 - AccuMax2021-04-07 Single-Use Holmium Laser Fiber
08714729784630 - AccuMax2021-04-07 Single-Use Holmium Laser Fiber
08714729784647 - AccuMax2021-04-07 Single-Use Holmium Laser Fiber
08714729784654 - AccuMax2021-04-07 Single-Use Holmium Laser Fiber
08714729802709 - AccuTrac2021-04-07 Single-Use Holmium Laser Fiber

Trademark Results [RotaLink]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ROTALINK
ROTALINK
74691391 2144951 Live/Registered
BOSTON SCIENTIFIC SCIMED, INC.
1995-06-16
ROTALINK
ROTALINK
74691390 2144950 Live/Registered
BOSTON SCIENTIFIC SCIMED, INC.
1995-06-16

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