Carto 3 D134402

GUDID 10846835022056

SPLIT HANDLE EXT. CABLE, 9' LG Supports catheter's with more than 20 electrodes

BIOSENSE WEBSTER INC.

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 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 ID10846835022056
NIH Device Record Key82161d21-2cf4-4385-9b4a-9178b412b3fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarto 3
Version Model NumberD134402
Catalog NumberD134402
Company DUNS020163218
Company NameBIOSENSE WEBSTER INC.
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 Datetrue
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(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com
Phone+1(800)729-9010
EmailRA-BWIUS-Complaints@its.jnj.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is opened
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS110846835022056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MTDCatheter, intracardiac mapping, high-density array

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

[10846835022056]

Ethylene Oxide


[10846835022056]

Ethylene Oxide


[10846835022056]

Ethylene Oxide


[10846835022056]

Ethylene Oxide


[10846835022056]

Ethylene Oxide


[10846835022056]

Ethylene Oxide


[10846835022056]

Ethylene Oxide


[10846835022056]

Ethylene Oxide


[10846835022056]

Ethylene Oxide


[10846835022056]

Ethylene Oxide


[10846835022056]

Ethylene Oxide


[10846835022056]

Ethylene Oxide


[10846835022056]

Ethylene Oxide


[10846835022056]

Ethylene Oxide


[10846835022056]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-09
Device Publish Date2021-07-30

On-Brand Devices [Carto 3]

10846835012576D128624
10846835009712D134401
10846835009439D129707
10846835009422D129704
10846835008906D128627
10846835008883D128622
10846835003925CY1212CT
10846835003918CY1210CT
10846835003871CR3434CT
10846835003857CR3425CT
10846835003826CG2025CT
10846835003802CB3434CT
10846835003796CB3412CT
10846835003789CB3410CT
10846835022056SPLIT HANDLE EXT. CABLE, 9' LG Supports catheter's with more than 20 electrodes

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