RotaLink™ Burr H802227680150

GUDID 08714729185826

Exchangeable Burr Catheter

BOSTON SCIENTIFIC CORPORATION

Mechanical atherectomy system, coronary, line-powered
Primary Device ID08714729185826
NIH Device Record Key53b3af9d-71fc-49dd-8b84-c00c82e200c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameRotaLink™ Burr
Version Model NumberH802227680150
Catalog NumberH802227680150
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
GS108714729185826 [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 Date2021-04-06
Device Publish Date2014-09-24

On-Brand Devices [RotaLink™ Burr]

08714729185864Exchangeable Burr Catheter
08714729185857Exchangeable Burr Catheter
08714729185840Exchangeable Burr Catheter
08714729185826Exchangeable Burr Catheter
08714729185819Exchangeable Burr Catheter
08714729185802Exchangeable Burr Catheter
08714729185796Exchangeable Burr Catheter
08714729126881Exchangeable Burr Catheter

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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