S300 Sereis

GUDID 08800053094160

AC 100-240V, 50/60Hz, 77-120VA(Camera)

DENTIS CO. ,LTD

Operating room light system

• Primary Device ID: 08800053094160
• NIH Device Record Key: 9cf658f2-e595-4272-ae01-3df37e68f754
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S300 Sereis
• Version Model Number: S300-32101
• 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	08800053094160 [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: 2025-02-27
• Device Publish Date: 2025-02-19

Devices Manufactured by DENTIS CO. ,LTD

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• 08800053084123 - ChecQ: 2025-04-08 ISQ measurement device
• 08800053092494 - ChecQPEG: 2025-04-08 ISQ meausrement PEG
• 08800053092500 - ChecQPEG: 2025-04-08 ISQ meausrement PEG
• 08800053092517 - ChecQPEG: 2025-04-08 ISQ meausrement PEG
• 08800053092524 - ChecQPEG: 2025-04-08 ISQ meausrement PEG
• 08800053092531 - ChecQPEG: 2025-04-08 ISQ meausrement PEG