FDA.reportPublic FDA data

Kolenda Salivary Introducer Set - 5.0

Primary DI
00850007350345
Brand
Kolenda Salivary Introducer Set - 5.0
Company
C2DX, INC.
Model
SDAS-5.0-18
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
00850007350345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007350345008500073503458500073503450850007350345

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.

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
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
00850007350383Sialocath Salivary Duct CatheterSDC-2.2-202026-02-10
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
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
00827002351660SialoCathCOOK INCORPORATEDOAJ2020-10-02