AM

2 catalogue numbers from AM96BLD5, listed by Wright Medical Technology, Inc., United States, under Knife, Surgical. 8 manufacturers in China are registered for this product code.

Registry build 21.09.26
8manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (2), Guangdong (2), Shanghai (1).

Chinese manufacturers registered for FDA product code EMF
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Nanjing J SUN Healthcare Co., Ltd. Nanjing Jiangsu Repacker / relabeller 56
Hangzhou Kangji Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Bothwin (Beijing) Medical Technology Co., Ltd. Beijng Beijing Manufacturer 25
Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 17
Foshan Cicada Dental Instrument Co., Ltd. Foshan Guangdong Manufacturer 15
Shenzhen Soga Technology Co., Ltd. Shenzhen Guangdong Manufacturer 7

Record

Regulatory record for AM
Listed by Wright Medical Technology, Inc., United States
FDA product code EMF
Device type Knife, Surgical
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published 2017-01-26
Record revised 2022-03-25 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for AM
Catalogue number Size Status
AM96BLD5 Multipack of 5 In distribution
AM96BLD1 Single Pack In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surgistar Surgistar, Inc. 285
Surtex Surtex Instruments Ltd 189
HU-Friedy HU-Friedy MFG Co., LLC 80
Zoll-Dental Zoll-Dental 72
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 59
Lazic Peter Lazic Gmbh 47
Millennium Avalign Technologies, Inc. 40
Aesculap Aesculap AG 38
Sklar Sklar Corporation 35
Stylus Surgical Specialties México, S. de R.L. de C.V. 32
V. Mueller Steris Corporation 31
Elmed Elmed, Inc. 30

Showing 12 of 122. All products under Knife, Surgical

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