Duns Number:328712260
Device Description: Pierceable Adhesive Seals for 96 Well Plates, MassChrom® Free Metanephrines in plasma
Catalog Number
81059
Brand Name
Accessorie
Version/Model Number
81059
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
-
Product Code
CHQ
Product Code Name
Chromatographic/Fluorometric Method, Catecholamines
Public Device Record Key
d45ee3cf-879f-44f1-9ee0-480fff75cf75
Public Version Date
September 07, 2020
Public Version Number
1
DI Record Publish Date
August 28, 2020
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 | 455 |
2 | A medical device with a moderate to high risk that requires special controls. | 92 |