FDA.reportPublic FDA data

Salivary Access Dilator Set

Primary DI
00850007350338
Brand
Salivary Access Dilator Set
Company
C2DX, INC.
Model
SDDS-18-20-HC
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
GCCDilator, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCCDilator, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850007350338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007350338008500073503388500073503380850007350338

GMDN Terms#

Term, Definition table
TermDefinition
Salivary gland dilator, single-useA sterile surgical instrument used during ear/nose/throat (ENT) surgery for enlarging a salivary gland cavity, canal, or duct, typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure. It is rod-like device, with a long, very slender body and a rounded nose at its distal end that is made of metal (e.g., stainless steel). 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
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
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
00810212930404SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930411SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930428SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930435SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930442SURGIPROSSurgipros, LLCGCC2026-05-28
00810212930459SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933504SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933511SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933528SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933535SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933542SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933559SURGIPROSSurgipros, LLCGCC2026-05-28
00810212933566SURGIPROSSurgipros, LLCGCC2026-05-28
00194613099848MSI Precision Specialty InstrumentsMed Saver, Inc.GCC2025-08-01
00194613094942MSI Precision Specialty InstrumentsMed Saver, Inc.GCC2024-08-15
00840183501945BR Surgical, LLCBR Surgical, LLCGCC2024-01-31
G586UR96282190Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282210Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282230Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282250Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282270Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282290Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282310Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
00840343718312GEN2SURGIX MEDICAL LLCGCC2023-09-05
00842331192661Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192678Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192685Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192692Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192708Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00840329829445Black & Black SurgicalBLACK & BLACK SURGICAL, INC.GCC2023-05-10