Duns Number:315539452
Device Description: The HistoCore PEGASUS is an automated tissue processor specifically designed for fixation, The HistoCore PEGASUS is an automated tissue processor specifically designed for fixation, dehydration, infiltration with intermedium and paraffin infiltration of human tissue specimens used for histological medical diagnosis by a pathologist, e.g. for cancer diagnosis. The HistoCore PEGASUS is designed for in vitro diagnostic applications.
Catalog Number
14048858005
Brand Name
HistoCore PEGASUS
Version/Model Number
000000014048858005
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IEO
Product Code Name
PROCESSOR, TISSUE, AUTOMATED
Public Device Record Key
f86652d5-dd68-4a66-8592-36d47860c7b4
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
November 02, 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 | 97 |