Duns Number:084042331
Device Description: ManaMed Lidocaine patches have 4% lidocaine providing odorless pain-relieving ointment on ManaMed Lidocaine patches have 4% lidocaine providing odorless pain-relieving ointment on a breathable adhesive patch. Same active ingredients as common national brands. No irritation, no burning, targets aggravated nerves, fast acting.
Catalog Number
LIDOOTC5
Brand Name
ManaMed
Version/Model Number
Lidocaine 4% pain releiving gel patch / 5 patches
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
Yes
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
OMW
Product Code Name
Adhesive Backed Thermal Skin Patches
Public Device Record Key
d678e24a-c52c-4d7a-8537-7a64a6d35c80
Public Version Date
July 11, 2022
Public Version Number
1
DI Record Publish Date
July 01, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 128 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |