Duns Number:047724226
Device Description: Transparent Adhesive Film 2 3/8" x 2 3/4" (100) consist of a thin polyurethane (PU) film, Transparent Adhesive Film 2 3/8" x 2 3/4" (100) consist of a thin polyurethane (PU) film, with a hypoallergenic, latex-free, adhesive that gently, yet securely, adheres to skin. They are breathable, sterile, transparent, and water-resistant. May be used as a primary or secondary dressing over skin wounds and areas with fragile skin providing a barrier to external contaminants.
Catalog Number
22001
Brand Name
Areza Medical
Version/Model Number
21209
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
cc9a68c3-8c21-48d2-8a0d-9e0aef220830
Public Version Date
November 02, 2021
Public Version Number
2
DI Record Publish Date
October 26, 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 |