Duns Number:544559614
Device Description: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface
Catalog Number
-
Brand Name
AUVON
Version/Model Number
EB10100N1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
Yes
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
7419183b-b812-4f75-a5e9-579546492aa8
Public Version Date
June 15, 2022
Public Version Number
1
DI Record Publish Date
June 07, 2022
Package DI Number
16971292002328
Quantity per Package
120
Contains DI Package
06971292002321
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 99 |