Duns Number:096372255
Device Description: INTL-NS PEDI CLOSED HEART SUPPLEMENT PACK
Catalog Number
89-9539-S
Brand Name
DeRoyal
Version/Model Number
89-9539-S
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRO
Product Code Name
General surgery tray
Public Device Record Key
aeeb57fd-9863-40bd-b01b-6bd572c0e4da
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
November 21, 2019
Package DI Number
50749756999767
Quantity per Package
30
Contains DI Package
00749756999762
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 |