Duns Number:086911794
Device Description: A flexible patch of fabric material, coated on one side with a pressure-sensitive adhesiv A flexible patch of fabric material, coated on one side with a pressure-sensitive adhesive and with an absorbent pad intended to cover a superficial wound (25 count).
Catalog Number
100673
Brand Name
Medi-First Plus Flexible Large Patch HW
Version/Model Number
100673
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
8451bc59-1361-4c39-809a-fc79cdfbf081
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
July 03, 2019
Package DI Number
50347682106732
Quantity per Package
36
Contains DI Package
00347682106737
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 110 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |