Duns Number:963856096
Device Description: MAYFIELD 2 Base Unit,Standard
Catalog Number
A3101SRL
Brand Name
MAYFIELD®
Version/Model Number
A3101SRL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FWZ
Product Code Name
Operating Room Accessories Table Tray
Public Device Record Key
bd9c7a83-c98a-4e6a-a49d-17a443ba1d31
Public Version Date
June 04, 2018
Public Version Number
1
DI Record Publish Date
May 03, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1079 |
2 | A medical device with a moderate to high risk that requires special controls. | 2066 |