FDA.report

TRUE DILATATION

Primary DI
00801741097447
Brand
TRUE DILATATION
Company
Bard Peripheral Vascular, Inc.
Model
0214512
Catalog number
0214512
Device description
TRUE™ DILATATION Balloon Valvuloplasty Catheter, 21 mm x 4.5 cm, 110 cm catheter
Published
2016-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OZTBalloon aortic valvuloplasty

Product Code Classifications

CodeDeviceSpecialtyClass
OZTBalloon Aortic ValvuloplastyCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00801741097447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741097447008017410974478017410974470801741097447

GMDN Terms

TermDefinition
Cardiac valvuloplasty catheterA 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags

DUNS number
135057938
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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