Duns Number:832696038
Device Description: V. Mueller TAMPER EVIDENT ARROW DBL-BARB GAS YELLOW
Catalog Number
AG2-1
Brand Name
V. Mueller
Version/Model Number
AG2-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 15, 2021
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
3f046e92-d275-46b4-9c4e-a6dfc4ed20be
Public Version Date
March 04, 2022
Public Version Number
4
DI Record Publish Date
August 11, 2017
Package DI Number
50885403426306
Quantity per Package
75
Contains DI Package
20885403426305
Package Discontinue Date
February 15, 2021
Package Status
Not in Commercial Distribution
Package Type
Case
| 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 |