Gsource

Liston Amputation Knife 6 3/4" blade

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

Who Else Makes It

Concentrated in Shanghai (1), Shandong (1).

Chinese manufacturers registered for FDA product code GDN
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

Record

Regulatory record for gSource
Listed by Gsource, LLC., United States
FDA product code GDN
Device type Knife, Amputation
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2020-02-18
Record revised 2022-08-19 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for gSource
Catalogue number Size Status
gS 65.8120 In distribution
gS 65.8125 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
American Medicals American Medicals 9
Aesculap Aesculap AG 8
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 7
Sklar® Sklar Corporation 6
Ambler Surgical Ambler Surgical, LLC 4
V. Mueller Carefusion 2200, Inc. 3
Integra® Miltex® Integra LifeSciences Production Corporation 2
Novo Surgical Inc. Novo Surgical, Inc. 2
Integra® Jarit® Integra LifeSciences Production Corporation 2
V. Mueller Steris Corporation 2
HNM Medical HNM Stainless, LLC. 2
Avalign Avalign Technologies, Inc. 2

Showing 12 of 21. All products under Knife, Amputation

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