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
62101
Brand Name
Medi-First Waterproof Latex Free First Aid Tape 1" 5 yds
Version/Model Number
62101
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
075fbe1b-f7f3-4231-8b3c-2c7fb937b0d9
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
July 03, 2019
Package DI Number
50347682621013
Quantity per Package
48
Contains DI Package
00347682621018
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 |