SOLED15 110305

GUDID 08050705890293

SOLED15 1-ARM CEILING STANDARD LINE

ACEM SPA

Fixed examination/treatment light

• Primary Device ID: 08050705890293
• NIH Device Record Key: 5d5f61a7-8794-4294-bfa7-9a096c69c7e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLED15
• Version Model Number: SOLED15 /SC1
• Catalog Number: 110305
• Company DUNS: 435188508
• Company Name: ACEM SPA
• 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	08050705890293 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-20
• Device Publish Date: 2020-01-31

On-Brand Devices [SOLED15]

• 08050705890309: SOLED15 2-ARM CEILING STANDARD LINE
• 08050705890293: SOLED15 1-ARM CEILING STANDARD LINE
• 08050705890286: SOLED15 TROLLEY ABPS
• 08050705890279: SOLED15 TROLLEY
• 08050705890262: SOLED15 WALL