FDA.report

TAUT

Primary DI
44026704418655
Brand
TAUT
Company
TELEFLEX INCORPORATED
Model
IPN004147
Catalog number
18400
Device description
TAUT CHOLANGIOGRAPHY CATHETER 10/BOX 4.5 FRENCH TIP X 30"
Published
2018-09-15
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
GBZCATHETER, CHOLANGIOGRAPHY

Product Code Classifications

CodeDeviceSpecialtyClass
GBZCatheter, CholangiographyGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24026704418651PackageGS110Not in Commercial Distribution
44026704418655PackageGS110Not in Commercial Distribution
04026704418657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2402670441865124026704418651
4402670441865544026704418655
04026704418657040267044186574026704418657

GMDN Terms

TermDefinition
Multi-purpose percutaneous drainage catheterA sterile flexible tube intended for percutaneous introduction into two or more abdominothoracic anatomies (nephrostomy, biliary, abscess, pleural, peritoneal, mediastinal) [i.e., multi-purpose] for intermittent or long-term drainage. It is available in various designs, shapes, and sizes, and is often designed to be connected to a pleural/peritoneal cavity suction (drainage) system. It may include disposable devices dedicated to catheter introduction. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
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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