Duns Number:832696038
Device Description: ROYCE TYMPANUM PERFORATORS STRAIGHT, BAYONET VERTICAL SPEAR BLADE 5.2 X 2MM WIDE OVERALL L ROYCE TYMPANUM PERFORATORS STRAIGHT, BAYONET VERTICAL SPEAR BLADE 5.2 X 2MM WIDE OVERALL LENGTH 7-1/8" (18.1CM)
Catalog Number
AU5740
Brand Name
V. Mueller
Version/Model Number
AU5740
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 23, 2019
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
JYO
Product Code Name
KNIFE, EAR
Public Device Record Key
5de66329-9fc5-45a9-b4a8-9ce6c3869d85
Public Version Date
December 11, 2019
Public Version Number
2
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 |