MitraClip™ CDS0706-XT

GUDID 05415067037404

Clip Delivery System

ST. JUDE MEDICAL, INC.

Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip
Primary Device ID05415067037404
NIH Device Record Key18bc1e11-06cc-427a-8939-e9f8779d7a0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMitraClip™
Version Model NumberCDS0706-XT
Catalog NumberCDS0706-XT
Company DUNS149818952
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter
Depth4 Millimeter
Width22 Millimeter
Length12 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067037404 [Primary]

FDA Product Code

NKMMitral valve repair devices

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-28
Device Publish Date2022-09-20

On-Brand Devices [MitraClip™]

05415067037435Clip Delivery System
05415067037404Clip Delivery System
05415067037381Clip Delivery System
05415067037367Clip Delivery System

Trademark Results [MitraClip]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MITRACLIP
MITRACLIP
78503491 3259174 Live/Registered
Evalve, Inc.
2004-10-21
MITRACLIP
MITRACLIP
77772245 4042528 Dead/Cancelled
Evalve, Inc.
2009-07-01
MITRACLIP
MITRACLIP
77173529 3365396 Live/Registered
Evalve, Inc.
2007-05-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.