FDA.report

TAUT

Primary DI
34026704742487
Brand
TAUT
Company
TELEFLEX INCORPORATED
Model
IPN925151
Catalog number
20018-M57
Device description
TAUT CHOLANGIOGRAPHY CATHETER 10/BOX 6.5 FRENCH TIP X 18 INCHES
Published
2022-09-23
Public version status
New
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
24026704742480PackageGS110In Commercial Distribution
34026704742487PackageGS110In Commercial Distribution
14026704656414PreviousGS10
14026704742483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2402670474248024026704742480
3402670474248734026704742487
1402670465641414026704656414
1402670474248314026704742483

GMDN Terms

TermDefinition
Multi-purpose percutaneous abdominothoracic drainage catheterA 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. Disposable devices dedicated to catheter introduction may be included with the device. 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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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