Electrosurgical, Cutting & Coagulation & Accessories

HF SURGERY GENERATOR 400KHZ for Urology, Gynecology, Surgery, for the connection of monopolar and bipolar accessories, international version for USA, monopolar connection Bovie, 3-pin, 4mm…

Registry build 21.09.26

HF SURGERY GENERATOR 400KHZ for Urology, Gynecology, Surgery, for the connection of monopolar and bipolar accessories, international version for USA, monopolar connection Bovie, 3-pin, 4mm plug, bipolar connection, Erbe, Valleylab, touch screen, color display, compatible with core nova, connection socket for neutral electrode cable international, U: 100-240VAC, 50/60Hz, Dim. (wxhxd) 300x159x416

65manufacturers in China registered for this device type
188catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GEI
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Hangzhou Kangji Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Amphenol Alden Products Company Shenzhen Guangdong Contract manufacturer 24
Hangzhou Endo Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Hong Qiangxing (Shen Zhen) Electronics Limited Shenzhen Guangdong Contract manufacturer 19
Shenzhen MED-Link Electronics Tech Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
ATL Technology DG,Ltd. Dongguan Guangdong Contract manufacturer 14
Jiangyin Sinbon Electronics Co Ltd Jiangyin Jiangsu Contract manufacturer 13
Guangzhou Huada Biotechnology Co., Ltd. Guangzhou Guangdong Contract manufacturer 9

Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories

Record

Regulatory record for Electrosurgical, Cutting & Coagulation & Accessories
Listed by Richard Wolf Gmbh, Germany
FDA product code GEI
Device type Electrosurgical, Cutting & Coagulation & Accessories
Device class Class 2
Regulation 21 CFR 878.4400
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k) K230194
Record published 2017-07-21
Record revised 2024-02-29 (version 10)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number
Storage Storage environment humidity 10 to 90 % RH; Storage environment temperature -20 to 60 °C
Sizes Outer diameter 1 to 10 mm; length 41 to 580 mm; length 3 to 5 m
Distribution end date 2024-05-26
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Electrosurgical, Cutting & Coagulation & Accessories
Catalogue number Size Per pack Status
815033 Length 3 m In distribution
82306 Outer Diameter 2 mm In distribution
8108035 Length 3 m In distribution
8391715 Outer Diameter 3.5 mm In distribution
8106033 Length 3 m In distribution
8379452 Length 310 mm In distribution
8383429 Length 340 mm In distribution
8106132 Length 3 m In distribution
844200006 Outer Diameter 4.9 mm In distribution
8383428 Outer Diameter 5 mm In distribution
8388203 Outer Diameter 2 mm In distribution
8393923 Length 319 mm In distribution
8379482 Length 310 mm In distribution
8393975 In distribution
8383423 Outer Diameter 5 mm In distribution
8242301 Outer Diameter 5 mm In distribution
8108031 Length 3 m In distribution
8108253 Length 5 m In distribution
8379462 Outer Diameter 3.5 mm In distribution
8108033 Length 3 m In distribution
844200005 Outer Diameter 7 mm In distribution
8391921 Outer Diameter 3.5 mm In distribution
82305 Outer Diameter 1.66666666666 mm In distribution
8108233 Length 3 m In distribution
2260021 Length 5 m In distribution
8388202 Outer Diameter 2 mm In distribution
8394704 Outer Diameter 5 mm In distribution
2260003 In distribution
815132 Length 3 m In distribution
8108135 Length 3 m In distribution
8393978 Outer Diameter 5 mm In distribution
8108032 Length 3 m In distribution
8108051 Length 5 m In distribution
838340 Outer Diameter 5 mm In distribution
8383426 Length 340 mm In distribution
82310 Length 400 mm In distribution
8388201 Outer Diameter 2 mm In distribution
838440 Length 450 mm In distribution
823031 Outer Diameter 1 mm In distribution
8108133 Length 3 m In distribution
8391742 Outer Diameter 3.5 mm In distribution
8383425 Outer Diameter 5 mm In distribution
8393925 Outer Diameter 5 mm In distribution
8106053 Length 5 m In distribution
82304 Outer Diameter 1.33333333333 mm In distribution
8108053 Length 5 m In distribution
8393705 Outer Diameter 5 mm In distribution
8108131 Length 3 m In distribution
815053 Length 5 m In distribution
8388200 Outer Diameter 2 mm In distribution
8384423 Length 420 mm In distribution
840430503 Withdrawn
8385901 Withdrawn
83991819 Outer Diameter 5 mm Withdrawn
8385903 Withdrawn
8108153 Length 5 m Withdrawn
8391911 Outer Diameter 3.5 mm Withdrawn
83017 Length 375 mm Withdrawn
8108151 Length 5 m Withdrawn
8393803 Outer Diameter 5 mm Withdrawn
8390008 Outer Diameter 3.5 mm Withdrawn
828233 Length 335 mm Withdrawn
840445409 Withdrawn
8393724 Outer Diameter 5 mm Withdrawn
815051 Length 5 m Withdrawn
82817 Length 375 mm Withdrawn
8394497 Outer Diameter 5 mm Withdrawn
8383974 Outer Diameter 4.7 mm Withdrawn
8383911 Outer Diameter 5 mm Withdrawn
83937065 Outer Diameter 5 mm Withdrawn
840442204 Withdrawn
840445300 Outer Diameter 5.0 mm Withdrawn
840442809 Withdrawn
8108055 Length 5 m Withdrawn
840442709 Withdrawn
815032 Length 3 m Withdrawn
8391254 Outer Diameter 3.5 mm Withdrawn
8391406 Outer Diameter 3.5 mm Withdrawn
8393823 Withdrawn
8399281 Outer Diameter 5 mm Withdrawn
8390204 Outer Diameter 3.5 mm Withdrawn
840442700 Outer Diameter 5.0 mm Withdrawn
8391716 Outer Diameter 3.5 mm Withdrawn
840445404 Withdrawn
840440403 Withdrawn
840445309 Withdrawn
8385944 Length 330 mm Withdrawn
8393793 Outer Diameter 5 mm Withdrawn
840442804 Withdrawn
8385942 Length 225 mm Withdrawn
840440400 Outer Diameter 5.0 mm Withdrawn
8242204 Length 275 mm Withdrawn
8765554 Withdrawn
8391014 Outer Diameter 3.5 mm Withdrawn
8393706 Withdrawn
8106051 Length 5 m Withdrawn
846464 Length 420 mm Withdrawn
8106052 Length 5 m Withdrawn
8393761 Withdrawn
8384911 Length 450 mm Withdrawn
815152 Length 5 m Withdrawn
8399181 Outer Diameter 5 mm Withdrawn
8383811 Outer Diameter 5.2 mm Withdrawn
8108052 Length 5 m Withdrawn
8106152 Length 5 m Withdrawn
840442800 Outer Diameter 5.0 mm Withdrawn
840550403 Withdrawn
8390006 Length 240 mm Withdrawn
8393726 Outer Diameter 5 mm Withdrawn
8393732 Outer Diameter 5 mm Withdrawn
838423 Outer Diameter 5 mm Withdrawn
8106054 Length 5 m Withdrawn
840445903 Withdrawn
8765621 Outer Diameter 1.8 mm 5 Withdrawn
840550400 Outer Diameter 5.0 mm Withdrawn
815052 Length 5 m Withdrawn
8383812 Outer Diameter 5.2 mm Withdrawn
8792695 2 Withdrawn
8106031 Length 3 m Withdrawn
844200003 Length 470 mm Withdrawn
8106032 Length 3 m Withdrawn
8390255 Outer Diameter 3.5 mm Withdrawn
844200004 Length 330 mm Withdrawn
840440500 Outer Diameter 5.0 mm Withdrawn
8394923 Length 444 mm Withdrawn
840440503 Withdrawn
8108132 Length 3 m Withdrawn
840431100 Outer Diameter 3.5 mm Withdrawn
8393924 Outer Diameter 5 mm Withdrawn
82717 Length 375 mm Withdrawn
8394705 Outer Diameter 5 mm Withdrawn
8390254 Outer Diameter 3.5 mm Withdrawn
8108152 Length 5 m Withdrawn
8390205 Length 240 mm Withdrawn
83992819 Outer Diameter 5 mm Withdrawn
8383913 Length 310 mm Withdrawn
8106034 Length 3 m Withdrawn
821180 Length 101 mm Withdrawn
864560 Length 325 mm Withdrawn
815054 Length 5 m Withdrawn
864565 Length 325 mm Withdrawn
8393704 Outer Diameter 5 mm Withdrawn
840442300 Outer Diameter 5.0 mm Withdrawn
8393725 Outer Diameter 5 mm Withdrawn
840442209 Withdrawn
821149 Length 98 mm Withdrawn
840432400 Outer Diameter 3.5 mm Withdrawn
8383813 Length 317 mm Withdrawn
8391255 Outer Diameter 3.5 mm Withdrawn
838323 Outer Diameter 5 mm Withdrawn
840442109 Withdrawn
8393976 Outer Diameter 5 mm Withdrawn
8384425 Withdrawn
8385902 Withdrawn
8393731 Outer Diameter 5 mm Withdrawn
815031 Length 3 m Withdrawn
840445900 Outer Diameter 5.0 mm Withdrawn
840442309 Withdrawn
840442704 Withdrawn
840442200 Outer Diameter 5.0 mm Withdrawn
840445400 Outer Diameter 5.0 mm Withdrawn
2352002 Withdrawn
8393781 Outer Diameter 5 mm Withdrawn
8394725 Outer Diameter 5 mm Withdrawn
4170954 Length 3 m 10 Withdrawn
840442104 Withdrawn
4170955 Length 3 m 10 Withdrawn
815034 Length 3 m Withdrawn
8383962 Length 383 mm Withdrawn
8384974 Outer Diameter 4.7 mm Withdrawn
8391204 Outer Diameter 3.5 mm Withdrawn
8385301 Outer Diameter 10 mm Withdrawn
840550103 Withdrawn
8394925 Length 362 mm Withdrawn
8391743 Outer Diameter 3.5 mm Withdrawn
8393974 Withdrawn
840445304 Withdrawn
8765613 Outer Diameter 1.8 mm 5 Withdrawn
8385951 Length 330 mm Withdrawn
8108155 Length 5 m Withdrawn
8383912 Outer Diameter 5 mm Withdrawn
840430500 Outer Diameter 3.5 mm Withdrawn
2030103 Withdrawn
8394094 Outer Diameter 5 mm Withdrawn
840442304 Withdrawn
840550100 Outer Diameter 5.0 mm Withdrawn
840442100 Outer Diameter 5.0 mm Withdrawn
8383819 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surgical Direct Surgical Direct, Inc. 5,729
Speedlock National Advanced Endoscopy Devices, Inc. 5,212
Stingray Surgical Products Stingray Surgical Products L.L.C. 4,647
Kirwan Kirwan Surgical Products, LLC. 1,901
Millennium Avalign Technologies, Inc. 1,779
DANmed Dannoritzer Medizintechnik GmbH & Co. KG 1,590
Elmed Elmed, Inc. 1,519
Symmetry Olsen Aspen Surgical Products, Inc. 1,219
Guenter Bissinger Medizintechnik GmbH Günter Bissinger Medizintechnik GmbH 1,117
Ambler Surgical Ambler Surgical, LLC 756
V. Mueller Steris Corporation 661
Aesculap Aesculap AG 544

Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & 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