Duns Number:595138793
Catalog Number
684057/A
Brand Name
Merit Medical®
Version/Model Number
00884450330739
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQO
Product Code Name
Catheter, intravascular, diagnostic
Public Device Record Key
75fc0d67-dcff-4d75-bd86-1a692618dfd8
Public Version Date
December 13, 2021
Public Version Number
2
DI Record Publish Date
September 17, 2021
Package DI Number
10884450330736
Quantity per Package
50
Contains DI Package
00884450330739
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. | 392 |