Duns Number:537208717
Device Description: The Riester otoscope is produced for illumination and examination of the auditory canal in The Riester otoscope is produced for illumination and examination of the auditory canal in combination with Riester ear specula
Catalog Number
2012-202
Brand Name
uni® I otoscope XL 3.5 V, plug-in-style
Version/Model Number
2012-202
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
K925759
Product Code
ERA
Product Code Name
Otoscope
Public Device Record Key
952c96a8-8d7a-42c7-98fb-f70d8558b5a8
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
January 28, 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 |