Duns Number:025460908
Device Description: GAUZE,HYDROGEL,SKINTEGRITY,4"X4"
Catalog Number
MSC6144
Brand Name
Medline
Version/Model Number
MSC6144
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
MGQ
Product Code Name
Dressing, wound and burn, hydrogel w/drug and/or biologic
Public Device Record Key
c5ff5ec8-d3f4-4e0f-8d99-adcf850e6663
Public Version Date
August 30, 2021
Public Version Number
1
DI Record Publish Date
August 21, 2021
Package DI Number
40080196669838
Quantity per Package
30
Contains DI Package
10080196669837
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |