Duns Number:080242300
Device Description: DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 6 FT. (1.8 M), SINGLE, PVC W DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 6 FT. (1.8 M), SINGLE, PVC WIRE 25/Pack
Catalog Number
DE-003772-25
Brand Name
GoldSelect
Version/Model Number
DE-003772-25
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"
Yes
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
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
8d9ee559-8c64-4b9e-b8d5-28a156e21add
Public Version Date
December 10, 2018
Public Version Number
1
DI Record Publish Date
November 08, 2018
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. | 1261 |