Sklar

Censitrac Ready Alexander Raspatory PED 6"

Registry build 21.09.26
6manufacturers in China registered for this device type
33catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (2), Shandong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GAC
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82

Record

Regulatory record for Sklar
Listed by Sklar Corporation, United States
FDA product code GAC
Device type Rasp, Surgical, General & Plastic Surgery
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2019-05-07
Record revised 2022-06-10 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Latex Labelled latex-free
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Sklar
Catalogue number Size Status
50-1945 In distribution
40-9054 In distribution
40-9051 In distribution
40-9050 In distribution
22-7760C In distribution
22-7760 In distribution
75-1220 In distribution
79-3102 In distribution
75-1215 In distribution
98-2125 In distribution
22-7560C In distribution
75-1211 In distribution
22-7660C In distribution
98-2124 In distribution
40-9068 In distribution
49-3360 In distribution
98-2123 In distribution
40-9052 In distribution
98-2126 In distribution
98-2121 In distribution
40-9066 In distribution
22-7660 In distribution
22-7560 In distribution
98-2122 In distribution
75-1210 In distribution
40-9067 In distribution
70-2265 In distribution
79-3101 In distribution
70-2260 In distribution
98-2120 In distribution
79-3123 In distribution
40-9053 In distribution
70-2261 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Rasp, Surgical, General & Plastic Surgery Depuy Spine, Inc. 102
American Medicals American Medicals 95
Integra® Jarit® Integra LifeSciences Production Corporation 55
Rasp, Surgical, General & Plastic Surgery Wright Medical Technology, Inc. 50
Surtex Surtex Instruments Ltd 47
Integra® Miltex® Integra LifeSciences Production Corporation 46
Aesculap Aesculap AG 45
Ambler Surgical Ambler Surgical, LLC 39
Innomed, Inc. Innomed, Inc. 39
Hayden Medical Hayden Medical Inc 36
Medline Medline Industries, Inc. 32
Millennium Avalign Technologies, Inc. 31

Showing 12 of 123. All products under Rasp, 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