AccessGUDID - DEVICE: MITRACLIP (08717648195921)

GUDID

Device Identifier (DI) Information

Brand Name: MITRACLIP
Version or Model: SGC0101
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SGC0101
Company Name: ABBOTT VASCULAR

Primary DI Number: 08717648195921
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 849716605 *Terms of Use

Device Description: STEERABLE GUIDE CATHETER, MITRACLIP US

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56280	Mitral valve tissue repair system	A system of devices intended for the percutaneous reconstruction of an insufficient mitral valve through tissue approximation using transvenous/transseptal techniques. It consists of a sterile clip delivery system (CDS), implantable metal clips, steerable delivery and guide catheters with a dilator (acts a conduit), and other devices to be sterilized prior to use. The steerable guide and CDS are typically steered and actuated through the use of control knobs, levers and torque translation techniques and guided by echocardiographic and fluoroscopic imaging. The clip is positioned and the mitral valve leaflets are coapted to reduce mitral regurgitation (MR). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DRA	CATHETER, STEERABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: afb15969-660e-451d-beab-60b02125c038
Public Version Date: May 31, 2018
Public Version Number: 3
DI Record Publish Date: November 26, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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