Duns Number:080390642
Device Description: 18 Gallon Black RCRA Disposable Container w/Grip Lid
Catalog Number
-
Brand Name
Mauser WIVA 4
Version/Model Number
NL060V4080ZWGR
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170513
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
6616b85c-026b-455a-bd2c-85e6884dbefa
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 15, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 36 |