IntellaNav StablePoint™ Cable M004RARC040

GUDID 00191506020408

Catheter Cable

BOSTON SCIENTIFIC CORPORATION

Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable
Primary Device ID00191506020408
NIH Device Record Keyc84889c5-2822-4734-ae33-9b1bdcebfc9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntellaNav StablePoint™ Cable
Version Model NumberM004RARC040
Catalog NumberM004RARC040
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter
Length200 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100191506020408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OADcatheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


[00191506020408]

Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-08
Device Publish Date2024-02-29

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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08714729042587 - Passport Kit2024-04-05 Balloon Dilatation Catheter Kit
08714729042594 - Passport Kit2024-04-05 Balloon Dilatation Catheter Kit
08714729042600 - Passport Kit2024-04-05 Balloon Dilatation Catheter Kit
08714729154921 - Passport2024-04-05 Balloon Dilatation Catheter
08714729154969 - Passport2024-04-05 Balloon Dilatation Catheter
08714729191872 - Passport2024-04-05 Balloon Dilatation Catheter

Trademark Results [IntellaNav StablePoint]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTELLANAV STABLEPOINT
INTELLANAV STABLEPOINT
90356679 not registered Live/Pending
Boston Scientific Scimed, Inc.
2020-12-03
INTELLANAV STABLEPOINT
INTELLANAV STABLEPOINT
87539785 not registered Live/Pending
Boston Scientific Scimed, Inc.
2017-07-24

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