AccessGUDID - DEVICE: MITRACLIP (08717648216800)

GUDID

Device Identifier (DI) Information

Brand Name: MITRACLIP
Version or Model: CDS0501
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CDS0501
Company Name: ABBOTT VASCULAR INC.

Primary DI Number: 08717648216800
Issuing Agency: GS1
Commercial Distribution End Date: September 06, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 964569052 *Terms of Use

Device Description: MITRACLIP NT CLIP DELIVERY SYSTEM

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
57790	Heart valve clip	An implantable device intended for the reconstruction of an insufficient mitral and/or tricuspid heart valve and reduction of valve regurgitation through the fixed approximation of the valve leaflets. It is typically implanted using a percutaneous clip delivery system (CDS) guided by echocardiographic and fluoroscopic imaging. It is typically made of implant grade metal alloys with a polyester fabric cover. Disposable devices associated with implantation (e.g., CDS and accessories) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NKM	Mitral valve repair devices

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: a745bc3a-fcec-492a-9209-065b28b4dec7
Public Version Date: February 05, 2021
Public Version Number: 5
DI Record Publish Date: September 22, 2016