Allen

S18061MA: Flexible Anesthesia Screen GE Part Number: 5402061 005

Registry build 21.09.26
25manufacturers in China registered for this device type
258catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Zhejiang (4), Shanghai (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FWZ
Manufacturer City Province Registered as Device types
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Ningbo Castle Medical Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 67
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Lianyungang Bronson Non-woven Products Co., Ltd. Lianyungang Jiangsu Contract manufacturer 16
Kunshan Jiehong Nonwoven Product Co., Ltd. Kunshan Jiangsu Contract manufacturer 12
Fenglin Industry Co., Ltd. Dongguan Guangdong Contract manufacturer 10
Hubei Yinkang Medical Equipment Co., Ltd. Xiaogan Hubei Contract manufacturer 8
Donghai Xingchen NON-Woven Products Co., Ltd. North Donghai Development Zone, Lianyungang Jiangsu Contract manufacturer 7
Jiangyin Puremed Jiangyin Jiangsu Contract manufacturer 7
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. Weihai Shandong Contract manufacturer 37

Showing 12 of 25. All 25 manufacturers in China registered for Operating Room Accessories Table Tray

Record

Regulatory record for Allen
Listed by Hill-ROM, Inc., United States
FDA product code FWZ
Device type Operating Room Accessories Table Tray
Device class Class 1
Regulation 21 CFR 878.4950
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2023-05-31
Record revised 2026-06-05 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Label carries lot or batch number, manufacturing date, serial number
Packaging Pack of 10
Distribution end date 2026-06-02

Catalogue Numbers

Catalogue numbers for Allen
Catalogue number Size Status
102001 In distribution
112003 In distribution
107002 In distribution
102001 In distribution
102001 In distribution
103003 In distribution
101006 In distribution
107002 In distribution
900111 In distribution
102001 In distribution
101003 In distribution
102001 In distribution
900111 In distribution
112003 In distribution
102001 In distribution
112002 In distribution
102001 In distribution
900111 In distribution
102001 In distribution
102001 In distribution
106002 In distribution
107002 In distribution
112004 In distribution
104004 In distribution
102007 In distribution
107002 In distribution
102001 In distribution
102002 In distribution
103004 In distribution
107004 In distribution
102001 In distribution
900111 In distribution
103004 In distribution
102005 In distribution
104004 In distribution
107002 In distribution
104003 In distribution
103005 In distribution
102001 In distribution
104004 In distribution
107002 In distribution
103003 In distribution
102005 In distribution
102007 In distribution
108001 In distribution
107004 In distribution
103002 In distribution
102001 In distribution
102001 In distribution
101003 In distribution
112005 In distribution
107002 In distribution
106002 In distribution
101001 In distribution
112005 In distribution
107005 In distribution
107002 In distribution
103003 In distribution
101006 In distribution
102001 In distribution
107002 In distribution
107002 In distribution
900111 In distribution
112006 In distribution
106002 In distribution
900111 In distribution
104002 In distribution
102001 In distribution
107004 In distribution
900111 In distribution
108001 In distribution
107002 In distribution
101006 In distribution
107002 In distribution
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102007 In distribution
102001 In distribution
102001 In distribution
900111 In distribution
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103004 In distribution
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102005 In distribution
103004 In distribution
107002 In distribution
101006 In distribution
102001 In distribution
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102007 In distribution
112006 In distribution
102001 In distribution
107002 In distribution
107002 In distribution
107002 In distribution
102001 In distribution
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102001 In distribution
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103003 In distribution
101003 In distribution
102002 In distribution
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102001 In distribution
102001 In distribution
107002 In distribution
102007 In distribution
900111 In distribution
107002 In distribution
107002 In distribution
102007 In distribution
112004 In distribution
107002 In distribution
112006 In distribution
103003 In distribution
101002 In distribution
107002 In distribution
112007 In distribution
107002 In distribution
104004 In distribution
102001 In distribution
107002 In distribution
107002 In distribution
107002 In distribution
107002 In distribution
101001 In distribution
103005 In distribution
101003 In distribution
102001 In distribution
104002 In distribution
103004 In distribution
107002 In distribution
102007 In distribution
101002 In distribution
107004 In distribution
102001 In distribution
101006 In distribution
104004 In distribution
108001 In distribution
102001 In distribution
102009 In distribution
108001 In distribution
102001 In distribution
106001 In distribution
112005 In distribution
107004 In distribution
112007 In distribution
107002 In distribution
102001 In distribution
106002 In distribution
900111 In distribution
104003 In distribution
112003 In distribution
104002 In distribution
102001 In distribution
102001 In distribution
101003 In distribution
900111 In distribution
107002 In distribution
107004 In distribution
103003 In distribution
102007 In distribution
900111 In distribution
106004 In distribution
102005 In distribution
900111 In distribution
104002 In distribution
107002 In distribution
101003 In distribution
101002 In distribution
900111 In distribution
900111 In distribution
102007 In distribution
102001 In distribution
103004 In distribution
107002 In distribution
107004 In distribution
107004 In distribution
102001 In distribution
107004 In distribution
107002 In distribution
104002 In distribution
103004 In distribution
104004 In distribution
102001 In distribution
108001 In distribution
107002 In distribution
900111 In distribution
104004 In distribution
103003 In distribution
103003 In distribution
102005 In distribution
107004 In distribution
107002 In distribution
102001 In distribution
112001 In distribution
107004 In distribution
102007 In distribution
102007 In distribution
900111 In distribution
108001 In distribution
102001 In distribution
103004 In distribution
106004 In distribution
103004 In distribution
108001 In distribution
102001 In distribution
104002 In distribution
107004 In distribution
104004 In distribution
107002 In distribution
106002 In distribution
900111 In distribution
102005 In distribution
102001 In distribution
900111 In distribution
102005 In distribution
107004 In distribution
102001 In distribution
102001 In distribution
101003 In distribution
107002 In distribution
107002 In distribution
101003 In distribution
102009 In distribution
102005 In distribution
102001 In distribution
107004 In distribution
112003 In distribution
103003 In distribution
107002 In distribution
101006 In distribution
900111 In distribution
102001 In distribution
107002 In distribution
900111 In distribution
102009 In distribution
102001 In distribution
102001 In distribution
102001 In distribution
102001 Withdrawn
103002 Withdrawn
102001 Withdrawn
102007 Withdrawn
106002 Withdrawn
107002 Withdrawn
102005 Withdrawn
102005 Withdrawn
107002 Withdrawn
102001 Withdrawn

Showing 250 of 258 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
SchureMed Schuerch Corporation 1,115
Scanlan® Surg-I-Band® color coding Scanlan International, Inc. 166
Operating Room Accessories Table Tray MID Central Medical 151
Operating Room Accessories Table Tray Smith & Nephew, Inc. 97
Schaerer Medical USA Schaerer Medical USA Inc 96
TSI Tedan Surgical Innovations, L.L.C. 87
De Mayo D2® Knee Positioner® Innovative Medical Products, Inc. 77
MorphBoard® Innovative Medical Products, Inc. 73
AXS Axcess Surgical Innovations, LLC 72
Mayfield® Integra Lifesciences Corporation 69
De Mayo Knee Positioner® Innovative Medical Products, Inc. 62
De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, Inc. 53

Showing 12 of 340. All products under Operating Room Accessories Table Tray

Recalls Naming This Product

3 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Allen
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
Baxter Healthcare Corporation UDI-DI 2024-02-14 Class II Under Investigation by firm Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surger 14 units
Baxter Healthcare Corporation UDI-DI 2023-05-18 Class II Device Design Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail. 1,010 units
Baxter Healthcare Corporation UDI-DI 2022-09-20 Class II Other the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity. 1 unit 2026-08-04

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