Duns Number:361955128
Device Description: GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizing radiati GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizing radiation detection.
Catalog Number
-
Brand Name
GammaPro Standard Probe with Tablet Carry Case
Version/Model Number
K0018C02
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IZD
Product Code Name
Probe, Uptake, Nuclear
Public Device Record Key
78893344-7fcd-4538-ad96-83ec90a35b4f
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 14, 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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |