Duns Number:039981550
Device Description: SabDex, USP, 26ml, red mono, no ink jet.(Sabourad Dextrose Agar, Red Tint Plate) For the c SabDex, USP, 26ml, red mono, no ink jet.(Sabourad Dextrose Agar, Red Tint Plate) For the cultivation of fungi.
Catalog Number
W70R
Brand Name
N/A
Version/Model Number
W70R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 23, 2022
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
-
Product Code
JSG
Product Code Name
Culture Media, Non-Selective And Non-Differential
Public Device Record Key
c96e55f7-a603-4a94-8686-c8b27cc0d12f
Public Version Date
March 23, 2022
Public Version Number
2
DI Record Publish Date
September 21, 2021
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 | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |