Duns Number:827221698
Device Description: Tens 7000 Conductive Sleeves includes (1) pair of sleeves, snap lead wires, insert and pac Tens 7000 Conductive Sleeves includes (1) pair of sleeves, snap lead wires, insert and pack of 3" round electrodes
Catalog Number
-
Brand Name
Tens 7000 Conductive Sleeves
Version/Model Number
DT7202-SLEEVE
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"
Yes
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
a477aa7a-e7bc-4e57-80f5-a2257b75fee3
Public Version Date
April 11, 2022
Public Version Number
3
DI Record Publish Date
November 20, 2019
Package DI Number
80092237622045
Quantity per Package
50
Contains DI Package
00092237622049
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 62 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 273 |
| U | Unclassified | 2 |