Duns Number:096372255
Device Description: C SECTION TRAY
Catalog Number
-
Brand Name
DeRoyal
Version/Model Number
89-2990
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OHM
Product Code Name
Cesarean section tray
Public Device Record Key
63b54579-5370-441e-9a43-8d1da0145633
Public Version Date
October 22, 2018
Public Version Number
3
DI Record Publish Date
November 24, 2016
Package DI Number
50749756309009
Quantity per Package
3
Contains DI Package
00749756309004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7041 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
| U | Unclassified | 3 |