Duns Number:690711189
Catalog Number
-
Brand Name
Corsair Armet
Version/Model Number
WCSAR150-14N
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
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
ac2d0366-7a30-4d44-a3b9-4691f07df8c5
Public Version Date
June 10, 2022
Public Version Number
8
DI Record Publish Date
September 16, 2016
Package DI Number
24547327108229
Quantity per Package
1
Contains DI Package
04547327108225
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 439 |