Duns Number:096372255
Device Description: OAKLAWN ANGIO KIT
Catalog Number
79-401109
Brand Name
DeRoyal
Version/Model Number
79-401109
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
DXT
Product Code Name
INJECTOR AND SYRINGE, ANGIOGRAPHIC
Public Device Record Key
a9c31e34-a94c-4a13-87ba-69672bf510e2
Public Version Date
April 10, 2019
Public Version Number
1
DI Record Publish Date
April 02, 2019
Package DI Number
50749756981946
Quantity per Package
20
Contains DI Package
00749756981941
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 |