E100 series(E1-M, E1-C, E1-W)

GUDID 08800053060820

INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33

DENTIS CO. ,LTD

Fixed examination/treatment room light

• Primary Device ID: 08800053060820
• NIH Device Record Key: 4bc81046-7dc2-407c-a86d-ab0f6a2b91af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E100 series(E1-M, E1-C, E1-W)
• Version Model Number: E1-M
• 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	08800053060820 [Primary]

FDA Product Code

• KZF: Device, Medical Examination, Ac Powered

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

On-Brand Devices [E100 series(E1-M, E1-C, E1-W)]

• 08800053060837: INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33
• 08800053060820: INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33
• 08800053060813: INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33
• 08800053060806: INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33
• 08800053060790: INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33
• 08800053060783: INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33
• 08800053060776: INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33
• 08800053060769: INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33