AccessGUDID - DEVICE: TRUE DILATATION (00801741091018)

GUDID

Device Identifier (DI) Information

Brand Name: TRUE DILATATION
Version or Model: 0244512
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0244512
Company Name: Bard Peripheral Vascular, Inc.

Primary DI Number: 00801741091018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 135057938 *Terms of Use

Device Description: TRUE™ DILATATION Balloon Valvuloplasty Catheter, 24 mm x 4.5 cm,110 cm catheter

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
OZT	Balloon aortic valvuloplasty

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Balloon Length, 4.5 Centimeters
Device Size Text, specify: Balloon Diameter, 24 Millimeters
Device Size Text, specify: Shaft Length, 110 Centimeters

Device Record Status

Public Device Record Key: 8992e24e-7161-46d0-9a74-901a0138d741
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 06, 2016