FDA.reportPublic FDA data

Gore TIPS Set

Primary DI
25391526210028
Brand
Gore TIPS Set
Company
CREGANNA UNLIMITED COMPANY
Model
TSET1016
Catalog number
TSET1016
Device description
Gore TIPS Set
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter
GBZCatheter, Cholangiography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2
GBZCatheter, CholangiographyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25391526210028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2539152621002825391526210028

GMDN Terms#

Term, Definition table
TermDefinition
Portosystemic needle setA collection of sterile devices which includes a portosystemic needle intended to create an artificial passage between the hepatic and portal veins (through the liver parenchyma) as part of a transjugular intrahepatic portosystemic shunt (TIPS) procedure. It includes a rigid metal portosystemic needle, a vascular guide catheter, and might include the initial percutaneous vascular introduction devices (e.g., sheath, dilator); neither a balloon catheter nor a shunt is included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French
Needle Gauge16Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool place

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985218606
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391526210017Gore TIPS® SheathTSTH1040TSTH10402016-09-23
05391526210109Lotus™ Introducer SetH749NTR180LIS-S2016-09-23
05391526210116Lotus™ Introducer SetH749NTR200LIS-L2016-09-23
05391526210000Gore TIPS NeedleTNDL1656TNDL16562016-09-23
05391526210031Zurpaz™ Steerable Sheath SetM004EPTMC85300M004EPTMC853002016-09-23
05391526210048Zurpaz™ Steerable Sheath SetM004EPTMCA85400M004EPTMCA854002016-09-23
05391526210055Zurpaz™ Steerable Sheath SetM004USMC85100M004USMC851002016-09-23
05391526210062Zurpaz™ Steerable Sheath SetM004USMCA85200M004USMCA852002016-09-23
05391526210079Zurpaz™ Steerable Sheath SetM004JPNMC85500M004JPNMC855002016-09-23
05391526210086Zurpaz™ Steerable Sheath SetM004JPNMCA85600M004JPNMCA856002016-09-23
05391526210253Attain Assist™ CS Access Catheter 146168-01146168-012019-01-14
05391526210154Trapper™ Exchange DeviceH74939330130H749393301302017-01-27

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