Duns Number:036981694
Catalog Number
578240733FW
Brand Name
Metro
Version/Model Number
5782
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
-
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,K140594
Product Code
MNW
Product Code Name
Analyzer, Body Composition
Public Device Record Key
d5ab2a68-8ee3-42ff-b7db-d05956b360af
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 02, 2018
Package DI Number
40077784027576
Quantity per Package
3
Contains DI Package
00077784027578
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 30 |