Duns Number:221297691
Device Description: THe Passport SmartTip Trocar is an access device that create and maintain a passageway for THe Passport SmartTip Trocar is an access device that create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures, such as general, gynecologic, thoracic, and urological procedures in adult and adolescent (12 to 21 years of age) populations. The Passport SmartTip Trocar is a single use disposable device, not to be resterilized.
Catalog Number
0260-285-100
Brand Name
Passport SmartTip Trocar
Version/Model Number
8.5mmx100mm
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
c3c51d55-683d-41fd-a3f3-65460e94b132
Public Version Date
April 28, 2021
Public Version Number
4
DI Record Publish Date
April 25, 2017
Package DI Number
10869257000303
Quantity per Package
6
Contains DI Package
00869257000306
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |