Biosense Webster D134903

GUDID 07613327361964

STRYKER SUSTAINABILITY SOLUTIONS, INC.

Cardiac mapping catheter, percutaneous, reprocessed
Primary Device ID07613327361964
NIH Device Record Key42887491-e028-49ef-894e-679cbc7a561e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiosense Webster
Version Model NumberD134903
Catalog NumberD134903
Company DUNS020198912
Company NameSTRYKER SUSTAINABILITY SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)888-3433
EmailRegulatoryAffairs2@stryker.com

Device Dimensions

Length115 Centimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327361964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NLHCATHETER, RECORDING, ELECTRODE, REPROCESSED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-03

On-Brand Devices [Biosense Webster]

07613327361995D134906
07613327361988D134904
07613327361971D134902
07613327361964D134903
07613327361957D134901
07613327361940D134905
07613327359930Diagnostic EP Catheter HALO XP, 7F
07613327359923Diagnostic EP Catheter ISMUS, 7F

Trademark Results [Biosense Webster]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOSENSE WEBSTER
BIOSENSE WEBSTER
85966667 5022859 Live/Registered
Cordis Corp.
2013-06-21
BIOSENSE WEBSTER
BIOSENSE WEBSTER
75793888 2550618 Live/Registered
BIOSENSE WEBSTER, INC.
1999-09-07

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