Duns Number:544557314
Catalog Number
-
Brand Name
Maxcon Sharps container
Version/Model Number
MA1421
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 10, 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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180984
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
078664b8-c3ab-43e8-a6c2-e97ad9fb2087
Public Version Date
October 15, 2019
Public Version Number
1
DI Record Publish Date
October 07, 2019
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |