Duns Number:306633756
Device Description: Cavity set of sizes 0.1, 0.5, 2 and 4 cc for Madsen Otoflex 100
Catalog Number
8-67-41300
Brand Name
Madsen
Version/Model Number
1012 OTOflex Cavity set
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"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K033645
Product Code
ETY
Product Code Name
Tester, Auditory Impedance
Public Device Record Key
d15987c0-c800-4b74-9688-f6d278fa38f1
Public Version Date
August 19, 2021
Public Version Number
1
DI Record Publish Date
August 11, 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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 398 |