COMORAL

GUDID 08800201500024

SMD Solution Co.,Ltd.

Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system Oral lavage system 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