Duns Number:015903922
Device Description: Weber-Loch Ear Curette, Fig. 2
Catalog Number
6.14.12
Brand Name
mytaMed
Version/Model Number
6.14.12
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 20, 2018
Issuing Agency
In HIBCC
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
JYG
Product Code Name
Curette, Ear
Public Device Record Key
ecf10250-1b46-4a87-b61c-128e24f177c1
Public Version Date
April 21, 2021
Public Version Number
2
DI Record Publish Date
December 20, 2018
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 | 861 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |