Duns Number:039981550
Device Description: Czapek Yeast Agar, deep fill, 15x100mm, order by the package of 10For the isolation and cu Czapek Yeast Agar, deep fill, 15x100mm, order by the package of 10For the isolation and cultivation of yeasts.
Catalog Number
W117
Brand Name
N/A
Version/Model Number
W117
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 21, 2021
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
JSJ
Product Code Name
Culture Media, Selective And Non-Differential
Public Device Record Key
bc9ea995-bf62-4c69-b3fb-94a7cd9010a1
Public Version Date
May 24, 2021
Public Version Number
2
DI Record Publish Date
June 05, 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 | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |