Water Unit

Basic Information

• Brand Name: Water Unit
• Primary DI: 07899581344015
• Version / Model: Syncrus G4A
• Catalog Number: 41000008205
• Company Name: Alliage S/A Indústrias Médico Odontológica
• Labeler DUNS: 898231451
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-01
• Public Version: 1
• Public Version Date: 2025-08-11
• Public Version Status: New
• Public Device Record Key: e0524c6c-c333-4330-bdb5-cc6c793c3442

Device Description

Water Unit Syncrus G4A

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EIA	Unit, Operative Dental	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34983	Dental cuspidor	A device shaped as a round bowl (a vessel), into which the patient will spit out the contents of their mouth during and after dental procedures. This vessel is usually a component of the dental delivery system and will typically have a water supply to allow the filling of a drinking vessel with warmed water for the patient to rinse out their mouth and provide the flushing of the cuspidor to wash away the waste (e.g., blood, tooth and material debris).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07899581344015	GS1

Premarket Submissions

Submission Number	Supplement Number
K964619	000