Duns Number:080242300
Device Description: REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: SILVER/CHLORIDE DISC, 6 FT. (1.8 M), SINGLE, REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: SILVER/CHLORIDE DISC, 6 FT. (1.8 M), SINGLE, SILICONE WIRE
Catalog Number
-
Brand Name
NOISEFREE
Version/Model Number
DE-S016315
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
K142159
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
15bfb59a-50dc-427a-a8ae-5b22a91ca150
Public Version Date
April 19, 2019
Public Version Number
1
DI Record Publish Date
April 11, 2019
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 |