SOLED15 110302

GUDID 08050705890262

SOLED15 WALL

ACEM SPA

Fixed examination/treatment light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light

Primary Device ID	08050705890262
NIH Device Record Key	24199d6f-2066-4dd1-9132-8869106f9aea
Commercial Distribution Status	In Commercial Distribution
Brand Name	SOLED15
Version Model Number	SOLED15 /W
Catalog Number	110302
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	08050705890262 [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