FAST SPLINT MATRIX

Basic Information

• Brand Name: FAST SPLINT MATRIX
• Primary DI: 66714700001231
• Version / Model: FSM18
• Company Name: Synca Marketing Inc
• Labeler DUNS: 247111768
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-11-16
• Public Version: 4
• Public Version Date: 2021-07-27
• Public Version Status: Update
• Public Device Record Key: 0d3e7a5e-f021-475b-9724-c042c54a6637
• Distribution End Date: 2021-07-26

Device Description

SILICONE WIDE APPLICATION TIPS (100)

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: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58498	Dental material mixing nozzle, sterile	A sterile device designed for mixing inactive compounds during a dental/maxillofacial procedure to produce a functional dental restorative/impression/regenerative material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental/maxillofacial application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of a certain number of tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	66714700001231	GS1
Unit of Use	00667147001231	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K102207	000