Duns Number:025460908
Device Description: HYDROGEL,SKINTEGRITY,1 OZ,BELLOWS BTL
Catalog Number
MSC6102
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
MSC6102
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
MGO
Product Code Name
Closure, wound, adhesive
Public Device Record Key
0dfb98df-ea5e-46a2-9495-4d07f1e4552a
Public Version Date
May 27, 2021
Public Version Number
1
DI Record Publish Date
May 19, 2021
Package DI Number
40080196669791
Quantity per Package
30
Contains DI Package
10080196669790
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |