Duns Number:896421240
Device Description: Genuine GRASS Nasopharyngeal Electrodes15cm- Reusable
Catalog Number
-
Brand Name
Grass
Version/Model Number
F-EPG-G-15CM-48
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 15, 2020
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
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
817d8d47-0391-4858-ac5b-a46a7e375761
Public Version Date
September 15, 2020
Public Version Number
3
DI Record Publish Date
August 17, 2016
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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 154 |