Duns Number:463337670
Device Description: Wprobe is a wireless ionizing radiation detector probe for use in the medical environment. Wprobe is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity.Wprobe is comprised of the probe and the software installed in a control unit that is compatible with its use.Wprobe is presented in 3 models: normal (Wprobe STD), High Sensitivity (Wprobe Hi-S) and laparoscopic (Wprobe LAP model).
Catalog Number
IC-1150
Brand Name
WPROBE
Version/Model Number
STD
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
Yes
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
8601b33f-fe07-4244-b113-24f48ab6bd1b
Public Version Date
December 09, 2021
Public Version Number
1
DI Record Publish Date
December 01, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |