Duns Number:302846407
Device Description: Neutral Electrode
Catalog Number
RS25A30
Brand Name
Skintact
Version/Model Number
RS25A30
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
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
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
f74c5189-4e37-463d-9157-4f5c0e23ec73
Public Version Date
June 05, 2020
Public Version Number
3
DI Record Publish Date
June 01, 2016
Package DI Number
29005531593248
Quantity per Package
50
Contains DI Package
19005531593241
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |
3 | A medical device with high risk that requires premarket approval | 17 |