Duns Number:063997360
Device Description: LDR Sterile Transparent Waterseal Dressing 4in x 4.75in 4 ea
Catalog Number
5736392
Brand Name
LEADER
Version/Model Number
5736392
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
NAC
Product Code Name
Dressing, wound, hydrophilic
Public Device Record Key
decc2ac6-75c3-441a-8970-b26b6688f23c
Public Version Date
April 11, 2022
Public Version Number
2
DI Record Publish Date
January 06, 2022
Package DI Number
50096295141172
Quantity per Package
24
Contains DI Package
00096295141177
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. | 39 |