Duns Number:966806150
Device Description: PERFORMA CLOTH 2" X 3.5" RECTANGLE - 4/PK
Catalog Number
551968
Brand Name
PERFORMA
Version/Model Number
551968
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)
-
Over the Counter (OTC)
Yes
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
48a342d1-d54f-4aa5-b7a3-50dff1d1b667
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
20885914070646
Quantity per Package
10
Contains DI Package
10885914070649
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |