Cardinal Health

Sterile Staple Remover KIT

Registry build 21.09.26
20manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (7), Jiangsu (6), Guangdong (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GDT
Manufacturer City Province Registered as Device types
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Ningbo Advan Electrical Co., Ltd. Cixi Zhejiang Contract manufacturer 5
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Zhejiang Lidesen Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 100
Ningbo Greetmed Medical Instruments Co., Ltd. Ningbo Zhejiang Specification developer 75
Orantech Inc. Shenzhen Guangdong Contract manufacturer 40
Tiger Medical Group Shanghai Shanghai Specification developer 38
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26
Shandong Haidike Medical Products Co., Ltd. Heze Shandong Manufacturer 22

Showing 12 of 20. All 20 manufacturers in China registered for Staple, Removable (Skin)

Record

Regulatory record for Cardinal Health
Listed by Cardinal Health 200, LLC, United States
FDA product code GDT
Device type Staple, Removable (Skin)
Device class Class 1
Regulation 21 CFR 878.4760
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2016-07-07
Record revised 2022-06-17 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date
Packaging Case of 50

Catalogue Numbers

Catalogue numbers for Cardinal Health
Catalogue number Size Status
HT06-8600 In distribution
16-1028CA In distribution
16-1028 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
microMend PRO Kitotech Medical Inc 14
Weck Teleflex Medical LLC 12
3M™ Precise™ 3M Company 11
Proximate Ethicon Endo-Surgery, Inc. 6
Michel Wound Clips Sontec Instruments, Inc. 5
Medline Industries, Inc. Medline Industries, Inc. 5
Multifire Premium Covidien LP 4
Ethicon Provision 4
microMend Kitotech Medical Inc 3
BandGrip® Micro-Anchor® Skin Closure Bandgrip Inc. 2
Arrow Teleflex Medical LLC 2
SM Covidien LP 2

Showing 12 of 28. All products under Staple, Removable (Skin)

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