Duns Number:832696038
Device Description: V. Mueller WIET MEASURING DEVICE 4.25MM OVERALL LENGTH 6-1/2" (16.5CM)
Catalog Number
AU12512425
Brand Name
V. Mueller
Version/Model Number
AU12512425
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JYZ
Product Code Name
ROD, MEASURING EAR
Public Device Record Key
0344d148-21cd-4046-84eb-c6a6569eccb6
Public Version Date
February 15, 2022
Public Version Number
3
DI Record Publish Date
July 13, 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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |