M310 Series (Ceiling, Mobile)

GUDID 08800053070089

RATING : AC 100-240 V, 50-60 Hz, 133-155 VA

DENTIS CO. ,LTD

Operating room light system

• Primary Device ID: 08800053070089
• NIH Device Record Key: a6f063c8-4776-42c8-8484-cb29472fd8ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M310 Series (Ceiling, Mobile)
• Version Model Number: M310
• Company DUNS: 694721181
• Company Name: DENTIS 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800053070089 [Primary]

FDA Product Code

• FTD: Lamp, Surgical

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: 2024-01-31
• Device Publish Date: 2024-01-23

Devices Manufactured by DENTIS CO. ,LTD

• 08800053070553 - s-Clean ScanHealing Abutment Screw: 2024-08-08 s-Clean ScanHealing Abutment Screw (DSSHSM03O)
• 08800053070560 - s-Clean ScanHealing Abutment Screw: 2024-08-08 s-Clean ScanHealing Abutment Screw (DSSHSM04O)
• 08800053070577 - s-Clean ScanHealing Abutment Screw: 2024-08-08 s-Clean ScanHealing Abutment Screw (DSSHSM05O)
• 08800053070584 - s-Clean ScanHealing Abutment Screw: 2024-08-08 s-Clean ScanHealing Abutment Screw (DSSHSM06O)
• 08800053070591 - s-Clean ScanHealing Abutment Screw: 2024-08-08 s-Clean ScanHealing Abutment Screw (DSSHSM07O)
• 08800053070706 - s-Clean ScanHealing Abutment: 2024-08-08 s-Clean ScanHealing Abutment (DSSH4820S)
• 08800053070713 - s-Clean ScanHealing Abutment: 2024-08-08 s-Clean ScanHealing Abutment (DSSH4830S)
• 08800053070720 - s-Clean ScanHealing Abutment: 2024-08-08 s-Clean ScanHealing Abutment (DSSH4840S)