Kerlix

X-Ray Detectable Laparotomy Sponges,Radiopaque, 4 Ply, Stretched, Unfolded

Registry build 21.09.26
266manufacturers in China registered for this device type
28catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (65), Jiangsu (64), Guangdong (29). 34 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NAB
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Jiangsu Guangda Medical Material Group Co., Ltd. Haian Jiangsu Contract manufacturer 32
Planet (Anhui) Medical Products Co., Ltd. Chuzhou Anhui Contract manufacturer 30
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23
Yiwu Haoding Medical Co., Ltd. Yiwu Zhejiang Contract manufacturer 23
Hefei Xingcheng Sanitary Products Co., Ltd. Hefei Anhui Contract manufacturer 21
Fomed Industries Inc Qian Jiang Hubei Contract manufacturer 19
Huizhou Foryou Medical Devices Co., Ltd. Huizhou Guangdong Contract manufacturer 18
Jianerkang Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 18

Showing 12 of 266. All 266 manufacturers in China registered for Gauze / Sponge,Nonresorbable For External Use

Record

Regulatory record for Kerlix
Listed by Cardinal Health, United States
FDA product code NAB
Device type Gauze / Sponge,Nonresorbable For External Use
Device class Class 1
Regulation 21 CFR 878.4014
Establishment Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2018-06-23
Record revised 2025-12-31 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number, expiry date
Storage Special storage condition: ;
Packaging Case of 100, case of 96, case of 600, pack_or_inner_pack of 50, case of 480, pack_or_inner_pack of 40
Sizes Width 2.25 to 16 in; length 4 to 25 in; length 3.1875 to 9.3 ft
Distribution end date 2028-06-01

Catalogue Numbers

Catalogue numbers for Kerlix
Catalogue number Size Per pack Status
3085 Width 6 in 5 In distribution
6035 Width 9.75 in 50 In distribution
6760 Width 4.50 in 5 In distribution
5072 Length 4 in 2 In distribution
8062 Length 25 in 5 In distribution
5042 Length 4 in 100 In distribution
7882 Length,4.125,yard; 100 In distribution
6120 Length 4 in 10 In distribution
4308 Width 7.75 in 2 In distribution
4588 Width 4 in 10 In distribution
2585 Length 6.75 in 2 In distribution
8095 Length 16 in 5 In distribution
6726 Length,4,yard; ; In distribution
1801 Width 2.25 in In distribution
3324 Length,4.125,yard; ; 12 In distribution
1892 Length,4.125,Yard; 100 In distribution
6735 Width 3.4375 in 96 Withdrawn
6720 Width 2.25 in Withdrawn
7310 Width 6 in 10 Withdrawn
6730 Length,4.125,yard; ; Withdrawn
6716 Length 9.3 ft Withdrawn
7884 Width 6 in 2 Withdrawn
7880 Length,4.125,yard; ; Withdrawn
1272 Length 8.75 in 100 Withdrawn
1167 Width 6 in 100 Withdrawn
6715 Width 4.50 in Withdrawn
4032 Width 4 in 100 Withdrawn
6725 Width 3.4375 in Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Techno-Aide Techno-Aide, Inc. 295
DeRoyal Deroyal Industries, Inc. 232
Medline Medline Industries, Inc. 194
Avaline Medical NJ LLC Avaline Medical NJ Limited Liability Company 132
McKesson Mckesson Medical-Surgical Inc. 112
Dukal Dukal LLC 112
Henry Schein Henry Schein, Inc. 110
MediChoice Owens & Minor Distribution, Inc. 73
Cardinal Health Cardinal Health 200, LLC 71
Medical Action Industries Medical Action Industries, Inc. 56
A Plus A Plus International, Inc 55
Curity Cardinal Health 53

Showing 12 of 308. All products under Gauze / Sponge,Nonresorbable For External Use

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