Duns Number:096372255
Device Description: CATH LAB PACK
Catalog Number
-
Brand Name
DeRoyal
Version/Model Number
89-8764
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
OEQ
Product Code Name
Angiography/angioplasty kit
Public Device Record Key
1c6426ba-24ba-4b27-9547-40bef74bffe4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
50749756903658
Quantity per Package
2
Contains DI Package
00749756903653
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 |