Duns Number:086911794
Device Description: A flexible band of fabric material coated on one side with a pressure-sensitive adhesive a A flexible band of fabric material coated on one side with a pressure-sensitive adhesive and with an absorbent pad intended to cover a superficial wound.
Catalog Number
644CAP
Brand Name
Fabric Adhesive Bandage 40
Version/Model Number
6444CAP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 08, 2019
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
3a4bedb9-9b05-44d2-a6a6-4c7428444347
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
July 03, 2019
Package DI Number
07310806444162
Quantity per Package
10
Contains DI Package
07310616444024
Package Discontinue Date
July 08, 2019
Package Status
Not 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 |