Comet™ II H74939359110

GUDID 08714729960140

Pressure Guidewire

BOSTON SCIENTIFIC CORPORATION

Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire
Primary Device ID08714729960140
NIH Device Record Key1e8f0df5-0b89-4298-9bf9-56d939e50007
Commercial Distribution StatusIn Commercial Distribution
Brand NameComet™ II
Version Model NumberH74939359110
Catalog NumberH74939359110
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 Kittrue
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

Outer Diameter0.36 Millimeter
Length185 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.36 Millimeter
Length185 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.36 Millimeter
Length185 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.36 Millimeter
Length185 Centimeter
Outer Diameter0.014 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729960140 [Primary]
GS108714729960140 [Primary]
GS108714729960140 [Primary]
GS108714729960140 [Primary]

FDA Product Code

DQXWire, guide, catheter
DQXWire, guide, catheter
DQXWire, guide, catheter
DQXWire, guide, catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

08714729960140 - Comet™ II2020-05-21Pressure Guidewire
08714729960140 - Comet™ II2020-05-21 Pressure Guidewire
08714729936176 - ACUITY™2020-05-19 Universal Cutter
08714729990901 - EXALT™2020-05-19 Controller
08714729990925 - EXALT™2020-05-19 Controller
08714729990932 - EXALT™2020-05-19 Controller
08714729990956 - EXALT™2020-05-19 Controller
00802526610400 - NA2020-05-13 BATTERY
00802526610615 - NA2020-05-13 STERILZABLE TELEMETRY WAND

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