Duns Number:017524666
Device Description: Mayo Stand Cover with SMS reinforcement. Disposable. Sterile. 23x55".
Catalog Number
A400-MAYO
Brand Name
AD Surgical
Version/Model Number
A400-MAYO
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"
-
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
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
c14bd2be-bc67-4ff4-8427-30f2928b0d67
Public Version Date
February 28, 2022
Public Version Number
1
DI Record Publish Date
February 18, 2022
Package DI Number
10814639025672
Quantity per Package
10
Contains DI Package
00814639025675
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 | 73 |
2 | A medical device with a moderate to high risk that requires special controls. | 121 |