Duns Number:537208717
Device Description: The Riester operation otoscope is produced for illumination and examination of the auditor The Riester operation otoscope is produced for illumination and examination of the auditory canal and for insertion of external instruments into the auditory canal.
Catalog Number
10561-301
Brand Name
ri-scope® OP-otoscope head (human)
Version/Model Number
10561-301
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
K950913
Product Code
ERA
Product Code Name
Otoscope
Public Device Record Key
5b8ba113-3a21-4e66-ba13-749a8fbd1349
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 |