Core Dynamics

10/12mm Open Lapsrosoopilc Adapter and Blunt Tip Trocar for Entree Plus and Entree II Cannula, Reusable

Registry build 21.09.26
7manufacturers in China registered for this device type
52catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HET
Manufacturer City Province Registered as Device types
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26
Scivita Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 19
Global Medical Production Co., Ltd. Jiaxing Zhejiang Manufacturer 10
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Cixi Zhejiang Manufacturer 8
Guangdong Optomedic Technologies, Inc. Foshan Guangdong Manufacturer 7

Record

Regulatory record for Core Dynamics
Listed by ConMed Corporation, United States
FDA product code HET
Device type Laparoscope, Gynecologic (And Accessories)
Device class Class 2
Regulation 21 CFR 884.1720
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k) K950457
Record published 2016-09-24
Record revised 2023-03-27 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: KEEP DRY
Packaging Box of 10, box of 5, box of 6, pouch of 10
Sizes Outer diameter 0.833 to 12 mm; length 90 to 110 mm; length 110 m
Distribution end date 2026-03-24

Catalogue Numbers

Catalogue numbers for Core Dynamics
Catalogue number Size Per pack Status
CD5080P Length 90 mm 10 In distribution
CD1406 In distribution
CD1930 Outer Diameter 5 mm 10 In distribution
CD4011P Outer Diameter 10 mm 10 In distribution
CD775 5-12 Millimeter Outer Diameter ENTREE II Cannula Valve 10 In distribution
CD4012P 10/12 Millimeter Outer Diameter ENTREE Plus Trocar 10 In distribution
CD650 Outer Diameter 5 mm 10 In distribution
CD5055P Outer Diameter 5.5 mm 10 In distribution
CD1935 Length 100 mm 10 In distribution
CD1970 Trocar/Cannula Procedure Kit 6 In distribution
CD1929 Outer Diameter 5 mm 10 Withdrawn
CD1404-BT Blunt Tip Trocar Withdrawn
CD1526 ENTREE II Cannula and Trocar Withdrawn
CD1982 Length 110 mm 10 Withdrawn
CD4012P-I 10/12 Millimeter Outer Diameter ENTREE Plus Trocar Withdrawn
CD1735 Outer Diameter 5 mm 10 Withdrawn
CD1923 Outer Diameter 5 mm 10 Withdrawn
CD1928 Outer Diameter 5 mm 10 Withdrawn
CD6GKP 5/5.5 Millimeter Gasket 5 Withdrawn
CD5055P-I Length 100 mm Withdrawn
CD1402 Withdrawn
CD1737 Length 100 mm 10 Withdrawn
CD1406-BT Blunt Tip Trocar Withdrawn
CD1922 Outer Diameter 5 mm 10 Withdrawn
CD1952 Outer Diameter 10 mm 10 Withdrawn
CD1722 Outer Diameter 5 mm 10 Withdrawn
CD6350P Outer Diameter 5 mm 10 Withdrawn
CD1403-BT Blunt Tip Trocar Withdrawn
CD1960 Length 100 mm 10 Withdrawn
CD1728 Outer Diameter 5 mm 10 Withdrawn
CD1950 Outer Diameter 10 mm 10 Withdrawn
CD4011P-I Outer Diameter 10 mm Withdrawn
CD1403 Laparoscopic Adapter and Blunt Tip Trocar Withdrawn
CD1708 Outer Diameter 5 mm 10 Withdrawn
CD1406 Laparoscopic Adapter and Blunt Tip Trocar Withdrawn
CD1961 Length 100 mm 10 Withdrawn
CD660 10-12 Millimeter Outer Diameter 10 Withdrawn
CD6378P 5-12 Millimeter Outer Diameter ENTREE II Valve/Reducer 10 Withdrawn
CD1404 Laparoscopic Adapter and Blunt Tip Trocar Withdrawn
CD1730 Outer Diameter 5 mm 10 Withdrawn
CD1525 ENTREE II Cannula and Trocar Withdrawn
CD1729 Outer Diameter 5 mm 10 Withdrawn
CD6300P-I Outer Diameter 5 mm Withdrawn
CD1723 Outer Diameter 5 mm 10 Withdrawn
CD1921 Outer Diameter 5 mm 10 Withdrawn
CD1406-R Open Laparoscopy Adapter Withdrawn
CD1706 Outer Diameter 5 mm 10 Withdrawn
CD1939 Outer Diameter 5 mm 10 Withdrawn
CD1975 Trocar/Cannula Procedure Kit 6 Withdrawn
CD1705 Outer Diameter 5 mm 10 Withdrawn
CD3GKL 10/12 Millimeter Gasket 5 Withdrawn
CD5080P-I 7/8 Millimeter Outer Diameter Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Endoplus Endoplus 448
Integra® MicroFrance® Integra Microfrance SAS 273
Symmetry Surgical® Aspen Surgical Products, Inc. 139
Laparoscope, Gynecologic (And Accessories) Karl Storz GmbH & Co. KG 119
Elmed Elmed, Inc. 96
Olympus Olympus Winter & IBE Gmbh 71
Symmetry Aspen Surgical Products, Inc. 48
DANmed Dannoritzer Medizintechnik GmbH & Co. KG 45
Laparoscope, Gynecologic (And Accessories) Richard Wolf Gmbh 37
Take-Apart Karl Storz GmbH & Co. KG 31
Blueendo Trokamed Gmbh 28
Olmypus Olympus Winter & IBE Gmbh 23

Showing 12 of 396. All products under Laparoscope, Gynecologic (And Accessories)

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