Passport SmartTip Trocar 0260-285-100

GUDID 10869257000303

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.

BELLUSCURA LTD.

Laparoscopic access cannula, single-use
Primary Device ID10869257000303
NIH Device Record Keyc3c51d55-683d-41fd-a3f3-65460e94b132
Commercial Distribution StatusIn Commercial Distribution
Brand NamePassport SmartTip Trocar
Version Model Number8.5mmx100mm
Catalog Number0260-285-100
Company DUNS221297691
Company NameBELLUSCURA LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-844-883-0940
Emailcustomerservice@belluscura.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100869257000306 [Primary]
GS110869257000303 [Package]
Contains: 00869257000306
Package: case [6 Units]
In Commercial Distribution

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-01-09
Device Publish Date2017-04-25

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