RotaLink™ Plus H749236310020

GUDID 08714729316411

Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device

BOSTON SCIENTIFIC CORPORATION

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Primary Device ID08714729316411
NIH Device Record Keye293db11-cd01-42fe-bd89-1f93bd0b2eeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameRotaLink™ Plus
Version Model NumberH749236310020
Catalog NumberH749236310020
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
GS108714729316411 [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™ Plus]

08714729316473Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729316466Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729316442Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729316411Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729228424Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729228394Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729228370Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729228363Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device

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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