Duns Number:654659689
Device Description: B615 to D630 upgrade kits option with new ROTOR
Catalog Number
H2401XF
Brand Name
D630 Upgrade
Version/Model Number
H2401XF
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
K111445
Product Code
KPS
Product Code Name
System, tomography, computed, emission
Public Device Record Key
3da7a092-90c2-4ed5-8d51-622af2e040c2
Public Version Date
October 27, 2022
Public Version Number
2
DI Record Publish Date
April 30, 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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 59 |