COMORAL

GUDID 08800201500024

SMD Solution Co.,Ltd.

Oral lavage system

• Primary Device ID: 08800201500024
• NIH Device Record Key: eb88a741-b4a4-441d-bec6-8e7849e97ae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMORAL
• Version Model Number: DCC1WA1A
• Company DUNS: 963328519
• Company Name: SMD Solution Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	08800201500024 [Primary]

FDA Product Code

• EFS: Unit, Oral Irrigation

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: 2024-05-22
• Device Publish Date: 2024-05-14