Duns Number:092815364
Device Description: Para-Pak EcoStain is a rapid staining procedure designed for the staining of intestinal pa Para-Pak EcoStain is a rapid staining procedure designed for the staining of intestinal parasites from stool fixed in non-mercury based PVA preservatives.
Catalog Number
801600
Brand Name
Modified Hemo-De
Version/Model Number
801600
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HYW
Product Code Name
Stain, Trichrome, Mallory'S
Public Device Record Key
7db495c5-c8b4-4459-ae43-851fd017a043
Public Version Date
September 29, 2020
Public Version Number
1
DI Record Publish Date
September 21, 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 | 149 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |
| 3 | A medical device with high risk that requires premarket approval | 1 |