Duns Number:753184944
Device Description: The scanner can be used to quickly enter the user ID, the ID on a basket’s anti-reflection The scanner can be used to quickly enter the user ID, the ID on a basket’s anti-reflection tag, or the lot or batch number of a reagent.
Catalog Number
S45.4508
Brand Name
HistoCore PELORIS
Version/Model Number
HistoCore PELORIS 3 Barcode Scanner 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
38cf387c-2b68-412e-bb18-3705cc803c80
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 |