Duns Number:080935429
Device Description: Carbon Electrode Tape Patch,125C-LT, Cloth, Low Tack, Slit Opening
Catalog Number
MT70000
Brand Name
Uni-Patch
Version/Model Number
MT70000
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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
74988108-43e0-459f-90f6-f632c0eb8874
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 30, 2018
Package DI Number
90884527021334
Quantity per Package
5000
Contains DI Package
20884527021335
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |