Duns Number:867673159
Device Description: ElectrotherapyAccessories Product Description: Electrode,4Pre-Gel'd,Rectang2x4.15,4/pkg
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
AGF-103
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 01, 2019
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
360936d8-40a7-459d-9742-fc2cecb93806
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
July 01, 2016
Package DI Number
10822383104314
Quantity per Package
320
Contains DI Package
50822383104312
Package Discontinue Date
June 01, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |