Passport SmartTip Trocar

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,…

Registry build 21.09.26

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.

46manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (15), Jiangsu (13), Zhejiang (7). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GCJ
Manufacturer City Province Registered as Device types
Hangzhou Kangji Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Hangzhou Endo Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13
Dongguan Honfield Precision Parts Co., Ltd. Zhangmutou, Dongguan Guangdong Contract manufacturer 8
Qingdao O-MEC Medical Technology Co., Ltd. Qingdao Shandong Contract manufacturer 6
Shenzhen Jingxintai Houseware Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
MediConcepts Technology (Shenzhen) Company Limited Shenzhen Guangdong Contract manufacturer 5
Qisda Electronics (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Barco (Suzhou) Healthcare Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 4
Jiangsu Bana Medical Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 4
Comhuge Medical Wire AND Harness Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 2

Showing 12 of 46. All 46 manufacturers in China registered for Laparoscope, General & Plastic Surgery

Record

Regulatory record for Passport SmartTip Trocar
Listed by Belluscura, LLC, United States
FDA product code GCJ
Device type Laparoscope, General & Plastic Surgery
Device class Class 2
Regulation 21 CFR 876.1500
Record published 2017-04-25
Record revised 2021-04-28 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case of 6

Catalogue Numbers

Catalogue numbers for Passport SmartTip Trocar
Catalogue number Size Status
8.5mmx100mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Elmed Elmed, Inc. 3,796
Surgical Direct Surgical Direct, Inc. 2,319
Novo Surgical Novo Surgical, Inc. 1,320
Elmed Incorporated Elmed, Inc. 911
Laparoscope, General & Plastic Surgery Karl Storz GmbH & Co. KG 774
Snowden-Pencer Steris Corporation 693
Millennium Avalign Technologies, Inc. 683
Hermann Medizintechnik GmbH Hermann Medizintechnik Gmbh 615
Clickline Karl Storz GmbH & Co. KG 582
V. Mueller Carefusion 2200, Inc. 553
Grasping forceps Sopro-Comeg GmbH 462
Gimmi Gimmi Gmbh 387

Showing 12 of 1,584. All products under Laparoscope, General & Plastic Surgery

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer