Dental unit

GUDID 06974416450015

FOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD.

Dental delivery system instrument unit, electric

• Primary Device ID: 06974416450015
• NIH Device Record Key: 12d5848e-37a6-45b3-81c1-cdd536832d65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental unit
• Version Model Number: Mare.1
• Company DUNS: 549331629
• Company Name: FOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974416450015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231845

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: 2024-03-20
• Device Publish Date: 2024-03-12

On-Brand Devices [Dental unit]

• 06974416450053: Mare.5
• 06974416450046: Mare.4
• 06974416450039: Mare.3
• 06974416450022: Mare.2
• 06974416450015: Mare.1
• 06974416450008: Mare