ROTAPRO™ H749394672380

GUDID 08714729999621

Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device

BOSTON SCIENTIFIC CORPORATION

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Primary Device ID08714729999621
NIH Device Record Keyd06b3ccb-ae22-4571-a8fd-2672c56a05b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameROTAPRO™
Version Model NumberH749394672380
Catalog NumberH749394672380
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

Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter
Guidewire Diameter2.38 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729999621 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-09
Device Publish Date2020-07-01

On-Brand Devices [ROTAPRO™]

08714729999638Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729999621Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729999614Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729999607Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729999591Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729999584Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729999577Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729999560Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729975106Rotational Atherectomy System
08714729975090Rotational Atherectomy System
08714729975083Rotational Atherectomy System
08714729975076Rotational Atherectomy System
08714729893424Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729893417Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729893400Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729893394Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729893387Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729893370Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729893363Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
08714729893356Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device

Trademark Results [ROTAPRO]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ROTAPRO
ROTAPRO
87059328 not registered Live/Pending
Boston Scientific Scimed, Inc.
2016-06-03

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