Duns Number:132286761
Device Description: Mynx Control VCD 6F 7F
Catalog Number
MX6760
Brand Name
MYNX CONTROL
Version/Model Number
MX6760
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P040044,P040044
Product Code
MGB
Product Code Name
Device, hemostasis, vascular
Public Device Record Key
e7d0bf8c-4932-4389-94f6-c07d617a87eb
Public Version Date
September 14, 2022
Public Version Number
4
DI Record Publish Date
October 22, 2018
Package DI Number
20862028000431
Quantity per Package
10
Contains DI Package
10862028000434
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 2 |