Duns Number:007924756
Device Description: All-Purpose Smart-Heal Hydrocolloid Gel Bandages, all one size, 20 mm x 60 mm
Catalog Number
-
Brand Name
H-E-B
Version/Model Number
041220728190
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
cc6aa2cb-33ba-471e-9484-8e3710f14865
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
August 30, 2019
Package DI Number
20041220728194
Quantity per Package
72
Contains DI Package
00041220728190
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |