Duns Number:804085293
Device Description: Advanced Waterproof Fast Healing Bandages, all one size, 3/4 IN x 3 IN (19 mm x 76 mm)
Catalog Number
-
Brand Name
Core Values
Version/Model Number
017276232141
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
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
351d0d6e-27a0-4673-bfda-e0a522d11066
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
February 28, 2020
Package DI Number
10017276232148
Quantity per Package
72
Contains DI Package
00017276232141
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |