Duns Number:315028860
Catalog Number
08900019190
Brand Name
Magnesium Gen.2
Version/Model Number
08900019190
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K983416
Product Code
JGJ
Product Code Name
PHOTOMETRIC METHOD, MAGNESIUM
Public Device Record Key
0e2309ff-4742-4321-a013-b516b61db346
Public Version Date
July 09, 2019
Public Version Number
1
DI Record Publish Date
July 01, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 289 |
2 | A medical device with a moderate to high risk that requires special controls. | 760 |
3 | A medical device with high risk that requires premarket approval | 63 |
U | Unclassified | 4 |