Duns Number:753184944
Device Description: The HistoCore PELORIS 3 dual retort rapid tissue processor automates preparation of tissue The HistoCore PELORIS 3 dual retort rapid tissue processor automates preparation of tissue samples for sectioning. This is achieved by transforming fixed specimens into wax infiltrated specimens by exposing them to a sequence of reagents in the tissue processor. Tissue samples subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis.
Catalog Number
49.0005
Brand Name
HistoCore PELORIS
Version/Model Number
HistoCore PELORIS 3 (100-120V)
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
IEO
Product Code Name
Processor, Tissue, Automated
Public Device Record Key
79aa1687-b357-4828-b74b-8775ea0e3bbf
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
July 20, 2022
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 | 28 |