Duns Number:989586482
Device Description: This device is intended for use as an endoscopic instrument(s) and/or camera port during m This device is intended for use as an endoscopic instrument(s) and/or camera port during minimally invasive abdominal surgery.The ASC TriPort15 is a sterile, disposable endoscopic multi-instrument port. The device consists of the following:• An Introducer that allows the insertion of the Base Retractor into the abdomen through an incision.• A Base Retractor that retracts in an abdominal incision to allow laparoscopic instruments pass through to the abdomen. • A Boot contains three instrument valves and two ports that allow insufflation of the abdomen or venting of electrocautery gases. The Boot maintains pneumoperitoneum when attached and allows specimen removal when detached.
Catalog Number
-
Brand Name
TriPort15
Version/Model Number
WA58015T
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"
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
K111407,K111407
Product Code
OTJ
Product Code Name
Laparoscopic Single Port Access Device
Public Device Record Key
ac84f936-fdff-49e8-851d-dbb507be6148
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 13, 2016
Package DI Number
05391530440080
Quantity per Package
5
Contains DI Package
05391530440097
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON OF 5
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |