Sklar®

Ligation Clips M/L 120BX Ster

Registry build 21.09.26
4manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code FZP
Manufacturer City Province Registered as Device types
Hangzhou Kangji Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Jiangsu Bana Medical Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 4
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Beijing Zksk Technology Co., Ltd. Beijing Beijing Contract manufacturer 38

Record

Regulatory record for Sklar®
Listed by Sklar Corporation, United States
FDA product code FZP
Device type Clip, Implantable
Device class Class 2
Regulation 21 CFR 878.4300
Establishment Specification developer, Repacker / relabeller, Manufacturer
510(k) K111930
Record published 2017-06-09
Record revised 2021-02-05 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Sklar®
Catalogue number Size Per pack Status
31-7303 120 In distribution
31-7302 120 In distribution
31-9301 120 In distribution
31-7300 120 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Weck Teleflex Medical LLC 321
Teleflex Teleflex Medical LLC 57
AtriClip™ LAA Exclusion System Atricure, Inc. 40
Aesculap Aesculap AG 19
Medline Medline Industries, Inc. 15
AtriClip Flex•v Atricure, Inc. 12
E-Pack Ethicon, Inc. 12
AtriClip® Pro•v™ LAA Exclusion System Atricure, Inc. 12
Titanium Ligation Clip Vesocclude Medical, LLC 11
SLS-Clip Vitalitec Surgical 10
SLS-Clip Vitalitec Peters Surgical 10
MirusTM Ligating Clip Meril Endo Surgery PVT. Ltd. 10

Showing 12 of 70. All products under Clip, Implantable

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