Avalign

Harken Auricle Clamp, No. 2, OL 250mm (9 7/8")

Registry build 21.09.26
16manufacturers in China registered for this device type
16catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Zhejiang (3), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GDJ
Manufacturer City Province Registered as Device types
Changzhou Health Microport Medical Device Co., Ltd. Changzhou Jiangsu Contract manufacturer 10
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Jiangsu JianYu Health Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 35
Suzhou Hengxiang IMP. & EXP. Co., Ltd. Suzhou Jiangsu Exporter 35
Shanghai Wilpower Industrial Co., Ltd. Shanghai Shanghai Exporter 33
Zhejiang Chuangxiang Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Suzhou Acmed Import & Export Co., Ltd. Suzhou Jiangsu Exporter 27
Tonglu Wanhe Medical Instrument Co., Ltd. Hangzhou Zhejiang Manufacturer 24
Asol Co., Ltd. Huaian Jiangsu Manufacturer 22

Showing 12 of 16. All 16 manufacturers in China registered for Clamp, Surgical, General & Plastic Surgery

Record

Regulatory record for Avalign
Listed by Avalign Technologies, Inc., United States
FDA product code GDJ
Device type Clamp, Surgical, General & Plastic Surgery
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2021-11-03
Record revised 2023-07-06 (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

Catalogue Numbers

Catalogue numbers for Avalign
Catalogue number Size Status
VM56-4621 In distribution
VM56-4616 In distribution
VM25-6110 In distribution
VM38-2239 In distribution
VM71-2263 In distribution
VM25-6116 In distribution
VM38-1951 In distribution
VM25-7176 In distribution
VM56-4611 In distribution
VM56-4489 In distribution
VM38-1953 In distribution
VM25-7178 In distribution
VM56-4633 In distribution
VM38-1972 In distribution
VM25-7179 In distribution
VM38-1971 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 666
Millennium Avalign Technologies, Inc. 131
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 127
Aesculap Aesculap AG 92
Sklar Sklar Corporation 79
Hayden Medical Hayden Medical Inc 73
Assi Accurate Surgical & Scientific Instruments Corp. 73
Boss Instruments Boss Instruments, Ltd. 66
Stille Hemostats Stille AB 66
Novo Surgical Novo Surgical, Inc. 64
Clamp, Surgical, General & Plastic Surgery George Tiemann & Co. 59
Clamp KLS-Martin L.P. 59

Showing 12 of 208. All products under Clamp, Surgical, 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