Duns Number:514870547
Device Description: Applier is an accessory used during minimally invasive surgery. The Applier is a standard Applier is an accessory used during minimally invasive surgery. The Applier is a standard cannula with a trigger that is used to introduce Virtual Ports' devices (EndoGrab, EndoLift or EndoClear) into the internal operating cavity via a port. After introduction into the operating cavity, the devices are applied to an organ and then anchored to the internal abdominal wall. The Applier is then removed, and the port remains available for use by other instruments. When the use of Virtual Port's devices is completed, the Applier is used for their retrieval from the internal operating cavity.
Catalog Number
AP045A
Brand Name
Applier 45cm
Version/Model Number
AP045A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
GDO
Product Code Name
Applier, Surgical, Clip
Public Device Record Key
374ad7c6-19f7-4530-a8b2-f023ab018faa
Public Version Date
July 01, 2021
Public Version Number
1
DI Record Publish Date
June 23, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |