Duns Number:832696038
Device Description: HOUGH EXCAVATOR BLADE 0.5MM WIDE, 0.8MM LONG ANGLED 49° ON ANGLED SHAFT OVERALL LENGTH 5-7 HOUGH EXCAVATOR BLADE 0.5MM WIDE, 0.8MM LONG ANGLED 49° ON ANGLED SHAFT OVERALL LENGTH 5-7/8" (14.9CM)
Catalog Number
AU20800
Brand Name
V. Mueller
Version/Model Number
AU20800
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
JYH
Product Code Name
EXCAVATOR, EAR
Public Device Record Key
1fa3851f-27b8-467c-ae48-8423925c5e7c
Public Version Date
September 03, 2018
Public Version Number
1
DI Record Publish Date
August 02, 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 |