Duns Number:832696038
Device Description: Genesis Tamper-Evident Arrows (Gas) - YELLOW
Catalog Number
AG2-2
Brand Name
V. Mueller
Version/Model Number
AG2-2
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
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
a0a8e3c3-4c78-464e-9f26-fea4bbcd81e2
Public Version Date
January 15, 2019
Public Version Number
3
DI Record Publish Date
August 11, 2017
Package DI Number
50885403160385
Quantity per Package
40
Contains DI Package
20885403160384
Package Discontinue Date
-
Package Status
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 |