Duns Number:086911794
Device Description: A non-sterile, long and narrow flexible band that is coated on one side with a pressure-se A non-sterile, long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a material designed to resist water permeation.
Catalog Number
61101
Brand Name
Medi-First Tri-Cut Waterproof Tape
Version/Model Number
61101
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
ec9ef06d-cc57-499f-8786-59455dbd92c7
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
July 03, 2019
Package DI Number
50347682611014
Quantity per Package
72
Contains DI Package
00347682611019
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 |