Duns Number:086911794
Device Description: A blue flexible water proof patch of plastic material, used for easy detection, coated on A blue flexible water proof patch of plastic material, used for easy detection, coated on one side with a pressure-sensitive adhesive and a sterile absorbent pad.
Catalog Number
67271
Brand Name
Great Grip BMD Water Tight Bandage Patch
Version/Model Number
67271
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
24e23fbd-fe36-447b-b7ae-7ed15d669a6b
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
July 12, 2019
Package DI Number
50347682672718
Quantity per Package
24
Contains DI Package
00347682672713
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 |