Duns Number:072943876
Device Description: Advanced All-Purpose Fast Healing Hydrocolloid Gel Bandages, all one size, 0.78 IN x 2.36 Advanced All-Purpose Fast Healing Hydrocolloid Gel Bandages, all one size, 0.78 IN x 2.36 IN (2.0 cm x 6.0 cm)
Catalog Number
-
Brand Name
TopCare health
Version/Model Number
036800467187
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
0e567d0c-bfac-4a69-8939-1b23a1e2dfdb
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
February 28, 2020
Package DI Number
10036800467184
Quantity per Package
72
Contains DI Package
00036800467187
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. | 27 |
| U | Unclassified | 1 |