Duns Number:047724226
Device Description: Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (2 Roll)is composed of a s Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (2 Roll)is composed of a soft, porous, semi-occlusive fabric backing covered with an adhesive layer. Fabripore adhesive tape is designed to decrease the risk of maceration while securing other dressings (primary) over wounds, catheters, tubings, electrodes, and any other device items that may need fixation. Conveniently perforated every 2 inches to be able to tear it by hand for easier handling. No latex is used in production.
Catalog Number
FT2X102
Brand Name
Areza Medical
Version/Model Number
FT2X102
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)
Yes
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
55968207-2ef3-4d4d-aee2-b2005074afab
Public Version Date
September 29, 2022
Public Version Number
2
DI Record Publish Date
October 25, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| U | Unclassified | 5 |