FDA.reportPublic FDA data

Sialocath Salivary Duct Catheter

Primary DI
00850007350383
Brand
Sialocath Salivary Duct Catheter
Company
C2DX, INC.
Model
SDC-2.2-20
Published
2026-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850007350383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007350383008500073503838500073503830850007350383

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-902-2239info@everismedical.com

Regulatory Flags#

DUNS number
116981210
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007350321Wire GuideC-SF-15-502026-02-10
00850007350338Salivary Access Dilator SetSDDS-18-20-HC2026-02-10
00850007350345Kolenda Salivary Introducer Set - 5.0SDAS-5.0-182026-02-10
00850007350352Kolenda Salivary Introducer Set - 6.0SDAS-6.0-182026-02-10
00850007350369NGage Salivary Stone ExtractorSSEB-1.7-115-82026-02-10
00850007350376NCircle Tipless Salivary Stone ExtractorSSEB-1.5-115-102026-02-10
00850007350390Advance Salivary Duct Balloon Catheter Set - 1.5SDBS-14-30-1.5-22026-02-10
00850007350406Advance Salivary Duct Balloon Catheter Set - 2.0SDBS-14-30-2.0-22026-02-10
00850007350413Advance Salivary Duct Balloon Catheter Set - 2.5SDBS-14-30-2.5-22026-02-10
00850007350420Advance Salivary Duct Balloon Catheter Set - 3.0SDBS-14-30-3.0-22026-02-10
10850007350090Mul-T-Pad8002-062-6122024-01-09
10850007350106Mul-T-Pad8002-062-6222024-01-09
10850007350120Mul-T-Pad8002-062-6262024-01-09
20850007350073Mul-T-Pad8002-062-0222024-01-09
20850007350110T/Pad8002-062-2222024-01-09
00850007350154TPS2TPS22024-01-09
00850007350161TPT9TPT92024-01-09
00850007350178TPIVTPIV2024-01-09
10850007350212SHAW SCALPEL7023-57102023-12-20
10850007350267SHAW SCALPEL7023-57122023-12-20

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
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
00827002351660SialoCathCOOK INCORPORATEDOAJ2020-10-02