Duns Number:753184944
Device Description: Used to print stick-on labels to attach to slides. The labelled slides are used on the BON Used to print stick-on labels to attach to slides. The labelled slides are used on the BOND instrument.
Catalog Number
S21.4615
Brand Name
BOND
Version/Model Number
Zebra GX430t Label Printer Spare
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
KPA
Product Code Name
Slide Stainer, Automated
Public Device Record Key
b57aec4d-6080-4708-a888-a2acafda968a
Public Version Date
July 28, 2022
Public Version Number
1
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 |