Duns Number:063997360
Device Description: LDR Electro TENS replacement gel pads 3 ea
Catalog Number
5297460
Brand Name
LEADER
Version/Model Number
5297460
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 11, 2022
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
NUH
Product Code Name
STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
Public Device Record Key
00c9e568-7937-49f1-b548-2f49d4e8ab6b
Public Version Date
October 12, 2022
Public Version Number
5
DI Record Publish Date
April 14, 2017
Package DI Number
30096295130363
Quantity per Package
4
Contains DI Package
00096295130362
Package Discontinue Date
October 11, 2022
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |