Duns Number:080935429
Device Description: Non-REM Polyhesive Patient Return Electrode
Catalog Number
E7506-05
Brand Name
Valleylab
Version/Model Number
E7506-05
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
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
K822572,K822572,K822572
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
f94b17ac-6311-4906-a0ff-815f78d42d1f
Public Version Date
June 05, 2020
Public Version Number
8
DI Record Publish Date
July 31, 2017
Package DI Number
20884521196589
Quantity per Package
10
Contains DI Package
10884521196582
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |