Medline

Broselow Trach, Chest Tube, & Cutdown

Registry build 21.09.26
36manufacturers in China registered for this device type
18catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (9), Jiangsu (8), Zhejiang (5). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LRP
Manufacturer City Province Registered as Device types
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shenzhen Senlede Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 33
Dongguan Shin YI Healthcare Products Factory Dong Guan Guangdong Contract manufacturer 30
Jiangsu Huadong Medical Device Industry Co., Ltd. Yangzhou Jiangsu Contract manufacturer 29
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
JIE GAO Plastic Products Co., Ltd. Dongguan Guangdong Contract manufacturer 11
Shenzhen HYS Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
Guangdong Huilin Packaging Technology Group Co., Ltd. Dongguan Guangdong Contract manufacturer 3
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105

Showing 12 of 36. All 36 manufacturers in China registered for Tray, Surgical

Record

Regulatory record for Medline
Listed by Centurion Medical Products Corporation, United States
FDA product code LRP
Device type Tray, Surgical
Device class Class 1
Regulation 21 CFR 878.4800
Premarket notification Exempt
Record published 2020-03-30
Record revised 2022-06-17 (version 3)

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 Contains natural rubber latex
Label carries lot or batch number, expiry date
Packaging Case of 20, case of 15, case of 12, case of 6, case of 24, case
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Medline
Catalogue number Size Status
DYNDA2710 In distribution
DYNDA2481A In distribution
DYNDA2725 In distribution
P429589A In distribution
SPEC0078B In distribution
DYNDR1071 In distribution
MNS8880B In distribution
DYNDA1212A In distribution
DYNDH1528 In distribution
MNS12465 In distribution
DYNDH1526 In distribution
DYNDA2369 In distribution
DYKM1751 In distribution
CHT2060 In distribution
DYNDA2715 In distribution
DYNDS1106 In distribution
DYNDA2721 In distribution
DYNDH1491 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 12,037
Centurion Centurion Medical Products Corporation 2,023
Medline Medline Industries, Inc. 773
PST Trays Ambler Surgical, LLC 128
AngioSystems Tray Angiosystems, Inc. 126
Tray, Surgical Wright Medical Technology, Inc. 123
Medin Corporation Ambler Surgical, LLC 96
Aligned Medical Solutions Aligned Medical Solutions 92
Stradis Stradis Healthcare 91
Cortera Spinal Fixation System Xtant Medical Holdings, Inc. 90
SteriBest Surgical Products Corp. 84
Elmed Elmed, Inc. 79

Showing 12 of 808. All products under Tray, Surgical

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Medline
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Medline Industries, LP – Northfield UDI-DI 2022-12-07 Class II Under Investigation by firm The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile. 4779 units

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