Duns Number:117359612
Device Description: REFEED MEDIUM ZERO-SERUM-PS
Catalog Number
10-360100
Brand Name
DHI Media & Controls
Version/Model Number
10-360100
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
-
Product Code
KIT
Product Code Name
MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE
Public Device Record Key
665d8efb-a3cf-435d-a304-c7ce27c50185
Public Version Date
October 29, 2018
Public Version Number
1
DI Record Publish Date
September 26, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 549 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |