Duns Number:066689993
Device Description: BODYMED SELF ADHESIVE ELECTRODE 2X2, FABRIC BACKING, 520/CASE
Catalog Number
CUS111
Brand Name
BodyMed
Version/Model Number
CUS111
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
94181013-3de5-4c86-aee3-c07674b8251c
Public Version Date
June 16, 2022
Public Version Number
5
DI Record Publish Date
October 13, 2016
Package DI Number
10815991020558
Quantity per Package
65
Contains DI Package
00815991020551
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |