Surgical Direct

Continuous Flow Operating Sheath, 7mm Diameter, with Instrument Channel, Examination Sheath, 5fr Instrument Channel, with Stopcock and Irrigation Control Stopcock, Outer Sheath for…

Registry build 21.09.26

Continuous Flow Operating Sheath, 7mm Diameter, with Instrument Channel, Examination Sheath, 5fr Instrument Channel, with Stopcock and Irrigation Control Stopcock, Outer Sheath for Continuous Flow with Suction Control Stopcock, 7mm Diameter Obturator

46manufacturers in China registered for this device type
2,319catalogue numbers in this listing

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 Surgical Direct
Listed by Surgical Direct, Inc., United States
FDA product code GCJ
Device type Laparoscope, General & Plastic Surgery
Device class Class 2
Regulation 21 CFR 876.1500
Establishment Repacker / relabeller
510(k) K974382
Record published 2022-11-23
Record revised 2025-11-05 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
Sizes Outer diameter 2 to 25 mm; length 15 to 470 cm; catheter gauge 3 to 27 Fr; needle gauge 10 to 19 G; angle 0 to 30 °; length 25.12 mm
Distribution end date 2025-11-04

Catalogue Numbers

Catalogue numbers for Surgical Direct
Catalogue number Size Status
SD13368-22 In distribution
SD56300-61 In distribution
SD77636-32B In distribution
SD77932-407 In distribution
SD13408-54 In distribution
SD908180000 In distribution
SD13038-11 In distribution
SD1357745 In distribution
SD13438-53 In distribution
SD773165 In distribution
SD15448-89 In distribution
SD77255-22I In distribution
SD232091 Catheter Gauge 7 Fr In distribution
SD30009CS Length 36 cm In distribution
SD42209A In distribution
SD 15508 Length 36 cm In distribution
SD14668-25 In distribution
SD13018-77 Length 36 cm In distribution
SD14128-87 Length 36 cm In distribution
SD1356545 In distribution
SD42219B In distribution
SD05309S Length 32 cm In distribution
SD7703-08-01 In distribution
SD77205-28L In distribution
SD48-2042LH In distribution
SD56534-22 In distribution
SD57-46109 In distribution
SD56940-22 In distribution
SD65972 In distribution
SD56400-17A In distribution
SD13408-89 In distribution
SD1271-59 Length 45 cm In distribution
SD74CL69 In distribution
SD15368-26 Length 36 cm In distribution
SD5514 In distribution
SD48-10151 In distribution
SD77070-483 In distribution
SD77536-86 In distribution
SD56400-82 In distribution
SD76270-16 In distribution
SD48-10001 In distribution
SD77255-68A1 In distribution
SD3086359 Outer Diameter 3.5 mm In distribution
SD13758-35 In distribution
SD15959-1040 In distribution
SD15378-61 In distribution
SD77205-29 In distribution
SD908202101 In distribution
SD16008-25 In distribution
SD13158-35 Length 32 cm In distribution
SD 1310832 Length 32 cm In distribution
SD77236-248I In distribution
SD77732-403E In distribution
SD3215551 Outer Diameter 10 mm In distribution
SD56540-32 In distribution
SD74CM69 In distribution
SD7720561-03 In distribution
SD12609 Outer Diameter 4 mm In distribution
SD23139 In distribution
SD12499.100 In distribution
SD77255-60 In distribution
SD77105-46 In distribution
SD56270-65A In distribution
SD77255-031 In distribution
SD56540-23 In distribution
SD 1490845 Length 45 cm In distribution
SD16182453 In distribution
SD48-300437 Length 35 cm In distribution
SD56534-33 In distribution
SD565126SS In distribution
SD77505-185 In distribution
SD77205-215 In distribution
SD 1550845 Length 45 cm In distribution
SD42289 Catheter Gauge 24 Fr In distribution
SD77515-21 In distribution
SD77205-6101 In distribution
SD92350910 In distribution
SD16180453 In distribution
SD77101-16B4 In distribution
SD16194519.100 In distribution
SD48-3033 In distribution
SD16009ss Length 36 cm In distribution
SD1381459s Length 45 cm In distribution
SD90820311 In distribution
SD10979 Length 38 cm In distribution
SD77502-02A In distribution
SD117553 In distribution
SD81089 In distribution
SD77505-86 In distribution
SD1050209B Length 20 cm In distribution
SD62530-14 In distribution
SD15908SR Length 32 cm In distribution
SD 1461845 Length 45 cm In distribution
SD56791-005 In distribution
SD61109 In distribution
SD14228-25 In distribution
SD4120935 Length 35 cm In distribution
SD101115THC In distribution
SD117163 In distribution
SD14128s Length 36 cm In distribution
SD14209s Length 33 cm In distribution
SD13028-65 In distribution
SD80-ESS15 Length 32 cm In distribution
SD90819230 In distribution
SD77236-272 In distribution
SD11649 Outer Diameter 5 mm In distribution
SD16688-11S In distribution
SD77745-404 In distribution
SD1005209 Length 20 cm In distribution
SD13438-63 In distribution
SD1034209 Length 20 cm In distribution
SD914559101 In distribution
SD48-302004 Length 35 cm In distribution
SD 13808 Length 36 cm In distribution
SD13769.100 In distribution
SD7705-6105 In distribution
SD 1570845 Length 45 cm In distribution
SD13809SL Length 36 cm In distribution
SD68719 Length 35 cm In distribution
SD77502-191 In distribution
SD77210-18 In distribution
SD77501-153 In distribution
SD14558-23 In distribution
SD30510 Outer Diameter 5 mm In distribution
SD10239 Outer Diameter 5 mm In distribution
SD1641BPW9 Outer Diameter 3 mm In distribution
SD56540-91 In distribution
SD161803 In distribution
SD 13068 Length 36 cm In distribution
SD 1555845 Length 45 cm In distribution
SD77900-52 In distribution
SD13687 In distribution
SD5870-14 In distribution
SD7750545-53 In distribution
SD82209 Length 400 cm In distribution
SD 1600832 Length 32 cm In distribution
SD73059 In distribution
SD41069 In distribution
SD 1490832 Length 32 cm In distribution
SD40919 Catheter Gauge 25 Fr In distribution
SD77255-0224 In distribution
SD13238-31 In distribution
SD23259 Catheter Gauge 7 Fr In distribution
SD74CML69 In distribution
SD90800317 In distribution
SD77255-11914 In distribution
SD16058-52 Length 36 cm In distribution
SD77155-159 In distribution
SD1375832 -15 In distribution
SD13238-87 In distribution
SD11059 Length 120 cm In distribution
SD16058-12 In distribution
SD13798-51 In distribution
SD1302832-15 In distribution
SD 1329845 Length 45 cm In distribution
SD77105-26 In distribution
SD13188-25 In distribution
SD77505-53-01S In distribution
SD05410 In distribution
SD133459 Length 33 cm In distribution
SD17520045.100 In distribution
SD40909A In distribution
SD30059CS Length 36 cm In distribution
SD 1300845 Length 45 cm In distribution
SD30829-10 In distribution
SD77255-17C In distribution
SD1185945 Length 45 cm In distribution
SD14668-55 In distribution
SD14178-15 In distribution
SD1542832-87 In distribution
SD48-9003 In distribution
SD40399 In distribution
SD30260S Outer Diameter 5 mm In distribution
SD11859 Length 33 cm In distribution
SD12669 In distribution
SD77605-35C In distribution
SD13808-21 In distribution
SD49255-05-OLY2 In distribution
SD14558-21 In distribution
SD 1660832 Length 32 cm In distribution
SD1271459 Length 45 cm In distribution
SD 14168 Length 36 cm In distribution
SD41369 Length 45 cm In distribution
SD13358-51 In distribution
SD16194522 In distribution
SD13188-21 Length 36 cm In distribution
SD16191945 In distribution
SD7700S In distribution
SD77102 In distribution
SD10299 Outer Diameter 5.5 mm In distribution
SD9161919100 In distribution
SD56775-01 In distribution
SD77515-63 In distribution
SD233290 In distribution
SD14198-77 In distribution
SD13567 In distribution
SD23308129 In distribution
SD 1326832 Length 32 cm In distribution
SD 15438 Length 36 cm In distribution
SD14318-23 In distribution
SD13439s Length 33 cm In distribution
SD77505.00 In distribution
SD40759 Catheter Gauge 19 Fr In distribution
SD26534-31 In distribution
SD30000S Length 36 cm In distribution
SD56534-32 In distribution
SD 13438 Length 36 cm In distribution
SD5516 In distribution
SD16339 Length 33 cm In distribution
SD565332 In distribution
SD 1412845 Length 45 cm In distribution
SD16729 Length 33 cm In distribution
SD13018-55 In distribution
SD 1302845 Length 45 cm In distribution
SD77156-731 In distribution
SD13519-71 In distribution
SD56400-58 In distribution
SD161814530 In distribution
SD10449 Outer Diameter 11 mm In distribution
SD90800220 In distribution
SD05308-710 In distribution
SD56512SS In distribution
SD 1382832 In distribution
SD 13778 Length 36 cm In distribution
SD77105-24 In distribution
SD77105-61-06 In distribution
SD90819040 In distribution
SD30359-10 In distribution
SD70059 Length 30 cm In distribution
SD16458-41 In distribution
SD13808-41 In distribution
SD16068-31 In distribution
SD30259-75 Length 33 cm In distribution
SD90820070 In distribution
SD13778-51 In distribution
SD300509 In distribution
SD 13368 Length 36 cm In distribution
SD13358-53 In distribution
SD56580-23 In distribution
SD1570833-87 In distribution
SD1376820 Length 20 cm In distribution
SD16458-21 In distribution
SD77932-443 In distribution
SD56400-21A In distribution
SD10329-10 Outer Diameter 10 mm In distribution
SD 1455932 In distribution
SD30849 Outer Diameter 3.5 mm In distribution
SD13188-51 In distribution
SD12209.100 In distribution
SD13408-79 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Elmed Elmed, Inc. 3,796
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
Integra® Jarit® Integra LifeSciences Production Corporation 374

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