Duns Number:009041773
Catalog Number
-
Brand Name
9.1MHZ Pencil Probe 7FT Contoured
Version/Model Number
832-1910-33
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JOP
Product Code Name
TRANSDUCER, ULTRASONIC
Public Device Record Key
6abf3a67-423b-48b1-98e9-7e7eb76c96d9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 15, 2017
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 434 |