FDA.report

TYSHAK®

Primary DI
04046964330322
Brand
TYSHAK®
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
610540
Catalog number
610540
Device description
PDC019 22MM X 4CM BALL CATH TYSHAK STD
Published
2016-08-09
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
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications

CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964330322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964330322040469643303224046964330322

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, Specify00Store at room temp

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)836-2228GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
784259751
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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