Sparkle™

Basic Information

• Brand Name: Sparkle™
• Primary DI: 10889950134068
• Version / Model: SP-SAWS
• Company Name: HU-FRIEDY MFG. CO., LLC
• Labeler DUNS: 005085972
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-15
• Public Version: 1
• Public Version Date: 2022-03-23
• Public Version Status: New
• Public Device Record Key: 11e4d093-5e83-4e24-a627-38e84ff7a95b

Device Description

Sparkle A/W Syringe Pack

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ECB	UNIT, SYRINGE, AIR AND/OR WATER	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65430	Dental delivery system irrigation handpiece tip	A rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris during a restorative or operative dental procedure. This is a single use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889950134068	GS1

Customer Contacts

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