AccessGUDID - DEVICE: NuCLEUS-X™ (04046964340307)

GUDID

Device Identifier (DI) Information

Brand Name: NuCLEUS-X™
Version or Model: 612038
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 612038
Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC

Primary DI Number: 04046964340307
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784259751 *Terms of Use

Device Description: PVN400 NUCLEUS X BALLOON 18X4X110 W5

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":	Yes
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Cardiac valvuloplasty catheter	A sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Cardiac valvuloplasty catheter

A sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
OZT	Balloon aortic valvuloplasty
DQY	CATHETER, PERCUTANEOUS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN080015	000
K081680	000

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: ROOM TEMP AWAY FROM SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7cc27cd-afec-48e5-8b69-1a8d9d6259a4
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 21, 2016