Duns Number:271968109
Device Description: EUROPROBE 3.2 PROBE
Catalog Number
SOE3211-AF
Brand Name
EUROPROBE
Version/Model Number
3.2
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
IZD
Product Code Name
Probe, Uptake, Nuclear
Public Device Record Key
9d4487f8-b06b-4172-b51f-a33eb458e311
Public Version Date
August 02, 2019
Public Version Number
1
DI Record Publish Date
July 25, 2019
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 | 34 |