Duns Number:080930531
Device Description: 2"x2" Cloth,
Catalog Number
-
Brand Name
Medical Science Private Label
Version/Model Number
203-493
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
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
57999274-0dc6-4b53-a88c-8112adffc2f0
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
January 07, 2019
Package DI Number
80092237900440
Quantity per Package
50
Contains DI Package
30092237900445
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 47 |
2 | A medical device with a moderate to high risk that requires special controls. | 449 |