Duns Number:332893028
Device Description: for Draffin bipod suspensions 40-335-00/40-335-10/40-335-01/40-335-11
Catalog Number
40-335-99
Brand Name
Magauran plate
Version/Model Number
40-335-99
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
-
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
LRC
Product Code Name
INSTRUMENT, ENT MANUAL SURGICAL
Public Device Record Key
656c385d-6ae3-4c72-9696-bda0ed804106
Public Version Date
October 04, 2022
Public Version Number
1
DI Record Publish Date
September 26, 2022
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 | 1960 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 97 |