Duns Number:068331990
Device Description: Sheer Adhesive Pads, sterile pads, 3 IN x 4 IN (76 mm x 101 mm)
Catalog Number
-
Brand Name
DGHealth
Version/Model Number
017276234824
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 07, 2020
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
e8a40014-325b-4ceb-9da3-f0b602d9c38e
Public Version Date
August 16, 2021
Public Version Number
2
DI Record Publish Date
September 07, 2020
Package DI Number
20017276234828
Quantity per Package
72
Contains DI Package
00017276234824
Package Discontinue Date
September 07, 2020
Package Status
Not 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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |
| U | Unclassified | 1 |