Duns Number:086911794
Device Description: A non-sterile, long and narrow flexible band of material, coated on one or both sides with A non-sterile, long and narrow flexible band of material, coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects.
Catalog Number
65699
Brand Name
Medi-First 1/2 x 2 5 yards
Version/Model Number
65699
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)
-
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
e4148fde-f095-45ca-a696-09b4496f658d
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
July 19, 2019
Package DI Number
50347682656992
Quantity per Package
200
Contains DI Package
00347682656997
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 |