Duns Number:753184944
Device Description: A barcode scanner, a built-in camera and an LCD screen t at displays the images captured b A barcode scanner, a built-in camera and an LCD screen t at displays the images captured by the camera. The scanner can be used for performing the same functions as a conventional barcode scanner and the built-in camera is used for capturing images of he baskets filled with cassettes.
Catalog Number
S45.4507
Brand Name
HistoCore PELORIS
Version/Model Number
HistoCore I-Scan Kit
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
2c2d19fa-e5cf-4b2d-b641-1f231130c328
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
July 18, 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 |