Duns Number:047724226
Device Description: Transparent Adhesive Film (Small) 2 3/8" x 2 3/4" 50/box - . High Quality Dressing. Featur Transparent Adhesive Film (Small) 2 3/8" x 2 3/4" 50/box - . High Quality Dressing. Features: -Water Proof -Provides Moist Environment -May Protect Fragile Skin and Wounds from Minor Mechanical Trauma -Barrier to Bacterial Invasion -Conformable -Hypoallergenic -No Latex in Used in the production of this Dressing. The products is manufactured for and distributed by Areza Medical, Dallas, Texas. VIDEO INSTRUCTION: please check the amazon page.
Catalog Number
TF22050
Brand Name
Areza Medical
Version/Model Number
TF22050
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
e0318f97-3dcc-4b84-881a-cf9711b499d5
Public Version Date
October 20, 2022
Public Version Number
1
DI Record Publish Date
October 12, 2022
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 |