Duns Number:184763290
Catalog Number
AD21T91WT-E
Brand Name
Merit Advance®
Version/Model Number
10884450151850
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRC
Product Code Name
Trocar
Public Device Record Key
94ffeb30-2764-4944-bcfc-ab84f376d3ee
Public Version Date
July 12, 2018
Public Version Number
1
DI Record Publish Date
June 11, 2018
Package DI Number
20884450151857
Quantity per Package
4
Contains DI Package
10884450151850
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 573 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8779 |