Duns Number:008965063
Device Description: WALG TENS THERAPY UNIT W/2 PADS SET
Catalog Number
030-PAIN-TENS
Brand Name
Walgreens
Version/Model Number
LT1102B
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
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
cfe17b34-ac0d-458c-99d8-6b9e18c69799
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
July 31, 2018
Package DI Number
10311917198719
Quantity per Package
36
Contains DI Package
00311917198712
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 75 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |
| U | Unclassified | 2 |