Duns Number:537208717
Device Description: With the Riester ear specula in combination with a Riester otoscope, the auditory canal is With the Riester ear specula in combination with a Riester otoscope, the auditory canal is illuminated and examined.
Catalog Number
14066-534
Brand Name
Pack with 1000 pcs., 40x25 pieces in polybag
Version/Model Number
14066-534
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
K932506
Product Code
EPY
Product Code Name
Speculum, Ent
Public Device Record Key
af664922-c568-4da8-b64a-3991bc41b44d
Public Version Date
February 05, 2021
Public Version Number
1
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 |