Duns Number:041810693
Catalog Number
9600
Brand Name
6 in. (15 cm) CheckMate Extension set
Version/Model Number
9600
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"
-
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
3b6bfd73-fcd0-42d8-8a6d-d12946bd5d47
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 07, 2016
Package DI Number
20634624096008
Quantity per Package
50
Contains DI Package
00634624096004
Package Discontinue Date
-
Package Status
-
Package Type
Shipper
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 168 |
U | Unclassified | 8 |