Duns Number:096372255
Device Description: Satchel Sheet
Catalog Number
59-0803NS
Brand Name
DeRoyal
Version/Model Number
59-0803NS
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)
Yes
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
e46f03bf-bd1d-4c67-aa38-e70213eb44af
Public Version Date
July 20, 2021
Public Version Number
1
DI Record Publish Date
July 12, 2021
Package DI Number
50749756024452
Quantity per Package
10
Contains DI Package
00749756024457
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 |