FDA.reportPublic FDA data

Yune-Klatte

Primary DI
00827002007406
Brand
Yune-Klatte
Company
COOK INCORPORATED
Model
G00740
Catalog number
YKC-19
Device description
Yune-Klatte Sialography Catheter
Published
2020-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OAJcatheter, drainage, intraoral/extraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAJCatheter, Drainage, Intraoral/ExtraoralGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002007406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002007406008270020074068270020074060827002007406

GMDN Terms#

Term, Definition table
TermDefinition
Salivary gland catheterA sterile, thin flexible tube intended to be used to access the salivary glands typically to introduce a contrast medium to enhance the radiographic images of the glands during sialography. It is typically made of metal or plastic materials [e.g., polyethylene (PE), polyurethane] and will have a short length of rigid or flexible cannula extending from its distal end. This device may also be used for intraoperative cholangiography. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850007350345Kolenda Salivary Introducer Set - 5.0C2DX, INC.OAJ2026-02-10
00850007350352Kolenda Salivary Introducer Set - 6.0C2DX, INC.OAJ2026-02-10
00850007350383Sialocath Salivary Duct CatheterC2DX, INC.OAJ2026-02-10
00827002007413Yune-KlatteCOOK INCORPORATEDOAJ2020-10-02
00827002011144ManashilCOOK INCORPORATEDOAJ2020-10-02
00827002011151ManashilCOOK INCORPORATEDOAJ2020-10-02
00827002011168ManashilCOOK INCORPORATEDOAJ2020-10-02
00827002013216RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002013223RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002013230RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002013445RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002013452RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002013469RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002013476RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002013544ManashilCOOK INCORPORATEDOAJ2020-10-02
00827002013629RabinovCOOK INCORPORATEDOAJ2020-10-02
00827002241299KolendaCOOK INCORPORATEDOAJ2020-10-02
00827002241329KolendaCOOK INCORPORATEDOAJ2020-10-02
00827002351660SialoCathCOOK INCORPORATEDOAJ2020-10-02