Duns Number:421072579
Catalog Number
5782F
Brand Name
Metro
Version/Model Number
578240733FW
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 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
K140594
Product Code
MNW
Product Code Name
Analyzer, Body Composition
Public Device Record Key
6eba05f9-8818-4673-ab38-a3d6149b6ee5
Public Version Date
January 01, 2019
Public Version Number
5
DI Record Publish Date
September 23, 2016
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. | 4 |