Catalog Number
BCTPL40-P
Brand Name
NA
Version/Model Number
BCTPL40-P
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2016
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
K942718,K942718,K942718
Product Code
GXY
Product Code Name
ELECTRODE, CUTANEOUS
Public Device Record Key
833ac3f7-ad8a-45ce-bf07-644abb5a4adf
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20653405016103
Quantity per Package
40
Contains DI Package
10653405016106
Package Discontinue Date
December 31, 2016
Package Status
Not in Commercial Distribution
Package Type
POUCH
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |