Allen
S18061MA: Flexible Anesthesia Screen GE Part Number: 5402061 005
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.
| 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
| 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
| 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 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 | |
| 102001 | In distribution | |
| 102007 | In distribution | |
| 102001 | In distribution | |
| 102001 | In distribution | |
| 900111 | In distribution | |
| 104002 | In distribution | |
| 103004 | In distribution | |
| 103003 | In distribution | |
| 102005 | In distribution | |
| 103004 | In distribution | |
| 107002 | In distribution | |
| 101006 | In distribution | |
| 102001 | In distribution | |
| 108003 | In distribution | |
| 107002 | In distribution | |
| 102007 | In distribution | |
| 112006 | In distribution | |
| 102001 | In distribution | |
| 107002 | In distribution | |
| 107002 | In distribution | |
| 107002 | In distribution | |
| 102001 | In distribution | |
| 103003 | In distribution | |
| 102001 | In distribution | |
| 101003 | In distribution | |
| 103003 | In distribution | |
| 101003 | In distribution | |
| 102002 | In distribution | |
| 107002 | In distribution | |
| 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
| 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.
| 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.