Tray, Surgical, Instrument

Sterilization Tray for Autoclavable Endoscope and Hardware

Registry build 21.09.26
105manufacturers in China registered for this device type
41catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FSM
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Mobility Source Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 26
Guangdong Shunde LQX Health Technology Inc. Foshan Guangdong Contract manufacturer 24

Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument

Record

Regulatory record for Tray, Surgical, Instrument
Listed by Stryker GmbH, Switzerland
FDA product code FSM
Device type Tray, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2018-09-24
Record revised 2025-04-16 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date, serial number
Storage Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 75 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 40 °C; Handling environment temperature -20 to 40 °C; Storage environment humidity 10 to 75 % RH
Sizes Outer diameter 3.4 mm
Distribution end date 2025-04-16
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Tray, Surgical, Instrument
Catalogue number Size Status
6400277010 In distribution
7900376010 In distribution
0233032105 In distribution
5901-1214 In distribution
5901-1213 In distribution
0295726100 In distribution
5450-800-278 Diameter: 7.0 Millimeter In distribution
5407-476-000 In distribution
0310034104 Outer Diameter 3.4 mm In distribution
234-020-120 In distribution
48110006 In distribution
48110004 In distribution
7900378010 In distribution
3910-500-575 In distribution
0295724140 In distribution
0233032104 In distribution
5407-478-000 In distribution
5450-800-279 Diameter: 11.0 Millimeter In distribution
0295800200 In distribution
1900-375-010 In distribution
234-020-123 In distribution
0295725140 In distribution
48110005 In distribution
0747031650 In distribution
0295723140 In distribution
0275722000 Diameter: 4.5 Millimeter In distribution
0295723130 In distribution
0275721000 Diameter: 6.0 Millimeter In distribution
234-010-520 In distribution
4607454010 In distribution
0233032116 In distribution
4405451010 In distribution
0295727101 In distribution
7900377010 In distribution
4405453010 In distribution
0295727100 In distribution
0295727202 In distribution
0406650400 In distribution
2000-004-049 Withdrawn
234-020-124 Withdrawn
0377030201 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IMS HU-Friedy MFG Co., LLC 2,710
Tray, Surgical, Instrument Synthes Gmbh 1,052
Tray, Surgical, Instrument Medtronic Sofamor Danek, Inc. 1,012
Hu-Friedy MFG Co., LLC. HU-Friedy MFG Co., LLC 666
Aptus Medartis Inc. 588
Acumed Acumed LLC 566
Aesculap Aesculap AG 532
Sklar Sklar Corporation 465
Hu-Friedy HU-Friedy MFG Co., LLC 438
Nordent Manufacturing Inc Nordent Manufacturing Inc 429
Level ONE KLS-Martin L.P. 341
Bahadir USA Bahadir USA LLC 300

Showing 12 of 3,212. All products under Tray, Surgical, Instrument

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