Duns Number:932471881
Catalog Number
-
Brand Name
EMSI 1.75 x 1.75 4 pack Samples
Version/Model Number
SRELEC0016
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 16, 2017
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
K050788
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
39936e4d-18c1-4531-99db-4aa45ef65755
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
May 16, 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. | 94 |