Duns Number:086911794
Device Description: A sterile water proof pad of plastic material, intended to cover a wound to provide or sup A sterile water proof pad of plastic material, intended to cover a wound to provide or support a moist wound healing environment, coated on one side with a pressure-sensitive adhesive.
Catalog Number
69550
Brand Name
Great Grip Advanced Healing Water Tight Bandages with Hydrocolloidal Ointment
Version/Model Number
69550
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)
-
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
4c8366be-f7c3-48c4-81bd-0a2dc6ac23f5
Public Version Date
July 22, 2019
Public Version Number
1
DI Record Publish Date
July 12, 2019
Package DI Number
50347682695502
Quantity per Package
24
Contains DI Package
00347682695507
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 110 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |