Weck

Disposable Standard 3/4" Blunt Needle Electrode Sterile Electrosurgical Electrode

Registry build 21.09.26
6manufacturers in China registered for this device type
18catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (3), Zhejiang (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HGI
Manufacturer City Province Registered as Device types
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Zhejiang Shuyou Surgical Instrument Co., Ltd. Huzhou Zhejiang Contract manufacturer 13
Ningbo Shun YE Medical Company, Ltd. Cixi Ningbo Zhejiang Contract manufacturer 8
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26
Shenzhen JPY ION-Tech. Co., Ltd. Shenzhen Guangdong Contract manufacturer 20
Zhejiang Jinhua Huatong Medical Appliance Co., Ltd. Jinhua Zhejiang Manufacturer 4

Record

Regulatory record for Weck
Listed by Teleflex Medical LLC, United States
FDA product code HGI
Device type Electrocautery, Gynecologic (And Accessories)
Device class Class 2
Regulation 21 CFR 884.4120
Establishment Specification developer, Complaint-file establishment, Manufacturer
Record published 2021-12-22
Record revised 2024-01-11 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Handling environment temperature -40 to 70 °C; Storage environment humidity 10 to 75 % RH; Handling environment humidity 10 to 100 % RH; Storage environment temperature 10 to 30 °C
Packaging Box of 24, bag of 24
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Weck
Catalogue number Size Status
IPN919101 In distribution
IPN029472 In distribution
IPN919095 In distribution
IPN919097 In distribution
IPN919103 In distribution
IPN029474 In distribution
IPN029469 In distribution
IPN029476 In distribution
IPN919098 In distribution
IPN029477 In distribution
IPN919100 In distribution
IPN919102 In distribution
IPN029470 In distribution
IPN029471 In distribution
IPN919096 In distribution
IPN029473 In distribution
IPN919099 In distribution
IPN029475 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bovie Aspen Surgical Products, Inc. 138
DeRoyal Deroyal Industries, Inc. 27
Electrocautery, Gynecologic (And Accessories) C R I 24
Greenwald Surgical Company, Inc. Grace Manufacturing Inc 22
Valleylab Aspen Surgical Products, Inc. 20
Argent Mckesson Medical-Surgical Inc. 19
Carrera Loop Electrodes Gynex Corporation 19
Radius Loop ELectrodes Gynex Corporation 13
Aesculap Aesculap AG 11
Leep Radius Electrode Coopersurgical, Inc. 10
Premier Premier Dental Products Co. 9
Megadyne Megadyne Medical Products, Inc. 9

Showing 12 of 70. All products under Electrocautery, 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