Duns Number:147363154
Device Description: De Mayo Adapt2Fit® Modular Knee Positioner Sterilization Case - 20" x 10" x 8"
Catalog Number
706-A2
Brand Name
De Mayo Adapt2Fit® Modular Knee Positioner
Version/Model Number
706-A2
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
-
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
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
3d2ab4ed-9cfa-4047-9377-c56882a5f96c
Public Version Date
February 23, 2022
Public Version Number
2
DI Record Publish Date
February 23, 2021
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 | 518 |