Duns Number:537208717
Device Description: The Riester headlights and head mirror have been manufactured to illuminate or throw light The Riester headlights and head mirror have been manufactured to illuminate or throw light onthe areas of the body to be examined.
Catalog Number
6072
Brand Name
clar N 55, LED 6 V, incl. lithium batteries
Version/Model Number
6072
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
HKF
Product Code Name
Mirror, Headband, Ophthalmic
Public Device Record Key
2ddde42e-57b7-40d5-838f-c33bf1be1703
Public Version Date
July 27, 2021
Public Version Number
1
DI Record Publish Date
July 19, 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 | 282 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 332 |