Duns Number:038000253
Device Description: ROBERT WOOD JOHNSON UNIVERSITY CUSTOM TRAY (WITHOUT CATHETER)
Catalog Number
-
Brand Name
N/A
Version/Model Number
TRAY #201
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 08, 2022
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
ba696677-eb5b-4ed8-852d-073097f4b873
Public Version Date
April 13, 2022
Public Version Number
2
DI Record Publish Date
July 03, 2019
Package DI Number
50884908054038
Quantity per Package
5
Contains DI Package
00884908054033
Package Discontinue Date
April 08, 2022
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |