Duns Number:025460908
Device Description: MAYO COVER
Catalog Number
MC10NSK
Brand Name
Medline
Version/Model Number
MC10NSK
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
MMP
Product Code Name
Cover, barrier, protective
Public Device Record Key
4fcf4b24-bb8d-4bbe-9e5f-507471ff0c3b
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
February 11, 2021
Package DI Number
40193489437127
Quantity per Package
2
Contains DI Package
10884389028414
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |