Duns Number:078497467
Device Description: EM50 RP,TENS Therapy Replacement Gel Pads, 6 Gel Pads
Catalog Number
664.98
Brand Name
Beurer
Version/Model Number
EM50RP
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
87d87aea-f0db-44f6-8eff-370532e555e3
Public Version Date
June 08, 2022
Public Version Number
1
DI Record Publish Date
May 31, 2022
Package DI Number
10850018808726
Quantity per Package
10
Contains DI Package
00850018808729
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |
| U | Unclassified | 2 |