FDA.reportPublic FDA data

SialoCath

Primary DI
00827002351660
Brand
SialoCath
Company
COOK INCORPORATED
Model
G35166
Catalog number
SDC-2.2-20
Device description
SialoCath Salivary Duct 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
00827002351660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002351660008270023516608270023516600827002351660

GMDN Terms#

Term, Definition table
TermDefinition
Salivary irrigation catheterA sterile, thin flexible tube intended to noninvasively access the salivary ducts for the introduction of fluids (e.g., saline, pharmaceutical solution) to treat conditions of the salivary duct [e.g., irrigation to remove salivary stones (calculi)]. 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
00827002007406Yune-KlatteCOOK INCORPORATEDOAJ2020-10-02
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