Duns Number:179135769
Device Description: H&E Stain Kit #1
Catalog Number
6190
Brand Name
Tissue-Tek Prisma®
Version/Model Number
6190
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
HZT
Product Code Name
REAGENT, SCHIFF
Public Device Record Key
f9231d01-a77c-4c3b-a026-020bdd77a85b
Public Version Date
December 23, 2019
Public Version Number
1
DI Record Publish Date
December 15, 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 | 733 |