Duns Number:013273872
Device Description: 14F MANTA Vascular Closure Device
Catalog Number
-
Brand Name
MANTA
Version/Model Number
2156
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
MGB
Product Code Name
Device, Hemostasis, Vascular
Public Device Record Key
3e814640-c47e-482f-8c87-7345fc76cba5
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
February 08, 2019
Package DI Number
00856279007109
Quantity per Package
5
Contains DI Package
00856279007079
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Box
Device Class | Device Class Description | No of Devices |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 2 |