Kolenda Salivary Introducer Set - 6.0

Basic Information

• Brand Name: Kolenda Salivary Introducer Set - 6.0
• Primary DI: 00850007350352
• Version / Model: SDAS-6.0-18
• Company Name: C2DX, INC.
• Labeler DUNS: 116981210
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-10
• Public Version: 1
• Public Version Date: 2026-02-18
• Public Version Status: New
• Public Device Record Key: 6ab42cfb-63c5-4129-adc3-321fc913fab6

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAJ	Catheter, Drainage, Intraoral/Extraoral	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46451	Salivary gland catheter	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850007350352	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]