Duns Number:316111251
Catalog Number
87200171
Brand Name
Zimmertrodes
Version/Model Number
87200171
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"
Yes
For Single-Use
Yes
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
K140340,K140340,K140340,K140340
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
ab481b4a-2f03-4a80-98f4-e313a0dc4b65
Public Version Date
March 18, 2021
Public Version Number
1
DI Record Publish Date
March 10, 2021
Package DI Number
24053815072915
Quantity per Package
8
Contains DI Package
14053815072918
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 9 |
2 | A medical device with a moderate to high risk that requires special controls. | 19 |