AccessGUDID - DEVICE: NuCLEUS-X™ (04046964340277)

GUDID

Device Identifier (DI) Information

Brand Name: NuCLEUS-X™
Version or Model: 612036
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 612036
Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC

Primary DI Number: 04046964340277
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784259751 *Terms of Use

Device Description: PVN416 NUCLEUS X BALLOON 30X5X110 W6

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17453	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.	Active	false

FDA Product Code

[?]

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

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: Keep away from sunlight
Special Storage Condition, Specify: Store at room temp
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b174b979-16af-499a-aa56-d7f954744d36
Public Version Date: September 07, 2023
Public Version Number: 8
DI Record Publish Date: September 21, 2016