MITRACLIP CDS0601-XTR

GUDID 08717648226366

MitraClip XTR Clip Delivery System

ABBOTT VASCULAR 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

• Primary Device ID: 08717648226366
• NIH Device Record Key: 06647d90-80b1-4264-9f4b-f7bb4c5e1ab0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MITRACLIP
• Version Model Number: CDS0601-XTR
• Catalog Number: CDS0601-XTR
• Company DUNS: 964569052
• Company Name: ABBOTT VASCULAR INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM
• Phone: +1(800)227-9902
• Email: AV.CUSTOMERCARE@AV.ABBOTT.COM

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717648226366 [Primary]

FDA Product Code

• NKM: Mitral valve repair devices

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-10
• Device Publish Date: 2018-07-09

On-Brand Devices [MITRACLIP]

• 08717648226366: MitraClip XTR Clip Delivery System
• 08717648226342: MitraClip NTR Clip Delivery System
• 08717648216800: MITRACLIP NT CLIP DELIVERY SYSTEM
• 08717648231025: Steerable Guide Catheter
• 08717648231001: MitraClip G4 Clip Delivery System XTW
• 08717648230981: MitraClip G4 Clip Delivery System XT
• 08717648230967: MitraClip G4 Clip Delivery System NTW
• 08717648230943: MitraClip G4 Clip Delivery System NT