Water Unit 41000008199

GUDID 07899581343957

Water Unit Syncrus G3

Alliage S/A Indústrias Médico Odontológica

Dental cuspidor

• Primary Device ID: 07899581343957
• NIH Device Record Key: 91eaaa69-b2c7-4180-9a54-147841994240
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Water Unit
• Version Model Number: Syncrus G3
• Catalog Number: 41000008199
• Company DUNS: 898231451
• Company Name: Alliage S/A Indústrias Médico Odontológica
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899581343957 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964619

FDA Product Code

• EIA: Unit, Operative Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-11
• Device Publish Date: 2025-08-01

On-Brand Devices [Water Unit]

• 07899581344015: Water Unit Syncrus G4A
• 07899581343957: Water Unit Syncrus G3
• 07899581343933: Water Unit Syncrus G2