Duns Number:266031462
Device Description: The PREMIO 40 Light is an active device intended to illuminate an area or a point of the p The PREMIO 40 Light is an active device intended to illuminate an area or a point of the patient's body in the visible spectrum by a light emission which can be filtered and / or frequency.
Catalog Number
112953
Brand Name
Premio 40 - Light
Version/Model Number
PREMIO 40
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KYT
Product Code Name
Light, Examination, Medical, Battery Powered
Public Device Record Key
7ccd57e2-ef74-4bb7-8557-eda7b6c19d2e
Public Version Date
August 04, 2021
Public Version Number
1
DI Record Publish Date
July 27, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |