Mayfield®
Service/Repair Loaner - MAYFIELD 2 Series Base Unit, Narrow
25manufacturers in China registered for this device type
69catalogue numbers in this listing
4recalls on this code
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 | Integra Lifesciences Corporation, 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, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-04-19 |
| Record revised | 2024-03-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A2600MP | In distribution | |
| A1113P | 7.7″ Length x 15.5″ Width x 26.1″ Height | In distribution |
| 437A2225P | 12.4″ Length x 10.3″ Width x 8.7″ Height | In distribution |
| A2079A | In distribution | |
| A1109P | 2.5″ Length x 1.63″ Width x 1.63″ Height | In distribution |
| A2079 | 40″ Length x 17.25″ Width x 7.25″ Height | In distribution |
| A1115 | 10.2″ Length x 6.4″ Width x 6.5″ Height | In distribution |
| A3101SRL | 23.5″ Length x 15.5″ Width x 10″ Height | In distribution |
| 437A2224 | 12.2″ Length x 10.4″ Width x 8.7″ Height | In distribution |
| A2079E | 40″ Length x 17.25″ Width x 7.25″ Height | In distribution |
| A1023 | 35.25″ Length x 32.5″ Width x 7.75″ Height | In distribution |
| A2111P | 17.7″ Length x 10.2″ Width x 6.8″ Height | In distribution |
| A2600RSRL | 9.1″ Length x 14.3″ Width x 24.2″ Height | In distribution |
| A2008SRL | 10.2″ Length x 6.2″ Width x 6.6″ Height | In distribution |
| A3100SRL | In distribution | |
| A2009P | 20.3″ Length x 14.3″ Width x 8.7″ Height | In distribution |
| A2009SRL | 20.3″ Length x 14.3″ Width x 8.7″ Height | In distribution |
| A2111 | 17.7″ Length x 10.2″ Width x 6.8″ Height | In distribution |
| A2600R | 9.1″ Length x 14.3″ Width x 24.2″ Height | In distribution |
| 437A2222 | In distribution | |
| A1115SRL | 10.2″ Length x 6.4″ Width x 6.5″ Height | In distribution |
| A3100P | In distribution | |
| A1064SRL | 10.4″ Length x 6.4″ Width x 6.7″ Height | In distribution |
| A1018 | 10.1″ Length x 6.3″ Width x 6.7″ Height | In distribution |
| A1113 | 7.7″ Length x 15.5″ Width x 26.1″ Height | In distribution |
| A1018SRL | 10.1″ Length x 6.3″ Width x 6.7″ Height | In distribution |
| A2101SRL | 8.7″ Length x 14.3″ Width x 24.1″ Height | In distribution |
| A2101P | 8.7″ Length x 14.3″ Width x 24.1″ Height | In distribution |
| A2600RP | 9.1″ Length x 14.3″ Width x 24.2″ Height | In distribution |
| A1064 | 10.4″ Length x 6.4″ Width x 6.7″ Height | In distribution |
| A3008SRL | In distribution | |
| A2111SRL | 17.7″ Length x 10.2″ Width x 6.8″ Height | In distribution |
| A1060 | 10.1″ Length x 6.5″ Width x 6.7″ Height | In distribution |
| A1060P | In distribution | |
| A1018P | 10.1″ Length x 6.3″ Width x 6.7″ Height | In distribution |
| A3008 | In distribution | |
| A1113SRL | 7.7″ Length x 15.5″ Width x 26.1″ Height | In distribution |
| A1015 | 16.2″ Length x 16.2″ Width x 5.6″ Height | In distribution |
| A3100 | In distribution | |
| 437A2225 | 12.4″ Length x 10.3″ Width x 8.7″ Height | In distribution |
| A3018 | In distribution | |
| 437A2224P | 12.2″ Length x 10.4″ Width x 8.7″ Height | In distribution |
| A2009 | 20.3″ Length x 14.3″ Width x 8.7″ Height | In distribution |
| A1110 | 3.25″ Length x 2.5″ Width x 3″ Height | In distribution |
| A3101P | 23.5″ Length x 15.5″ Width x 10″ Height | In distribution |
| 41B1171A | In distribution | |
| 449A1030 | 17.7″ Length x 10.1″ Width x 7″ Height | In distribution |
| A1115P | 10.2″ Length x 6.4″ Width x 6.5″ Height | In distribution |
| 41B1171B | In distribution | |
| A2008P | 10.2″ Length x 6.2″ Width x 6.6″ Height | In distribution |
| A2008 | 10.2″ Length x 6.2″ Width x 6.6″ Height | In distribution |
| A3101 | 23.5″ Length x 15.5″ Width x 10″ Height | In distribution |
| A3008P | In distribution | |
| A1064P | 10.4″ Length x 6.4″ Width x 6.7″ Height | In distribution |
| 41B1171C | In distribution | |
| A2101 | 8.7″ Length x 14.3″ Width x 24.1″ Height | In distribution |
| A2079EP | In distribution | |
| A2600M | 9″ Length x 14.6″ Width x 24.2″ Height | In distribution |
| A2079SRL | 40″ Length x 17.25″ Width x 7.25″ Height | In distribution |
| A2079P | 40″ Length x 17.25″ Width x 7.25″ Height | In distribution |
| A0077 | 28.5″ Length x 28.5″ Width x 8.75″ Height | In distribution |
| A1116 | In distribution | |
| A1109 | 2.5″ Length x 1.63″ Width x 1.63″ Height | In distribution |
| A1015P | In distribution | |
| A2102P | Withdrawn | |
| 437A2225SRL | 12.4″ Length x 10.3″ Width x 8.7″ Height | Withdrawn |
| A2029P | Withdrawn | |
| 431A1013 | 1.38″ Length x 0.63″ Width x 0.63″ Height | Withdrawn |
| 437A2224SRL | 12.2″ Length x 10.4″ Width x 8.7″ Height | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SchureMed | Schuerch Corporation | 1,115 |
| Allen | Hill-ROM, Inc. | 258 |
| 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 |
| 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
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-12-19 | Class II | Nonconforming Material/Component | Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use. | 1053 Units | 2017-02-22 |
| 2012-12-21 | Class II | Device Design | Integra determined there is a possibility that the Base Units may break during use. | 96 units | 2013-07-10 |
| 2012-11-05 | Class II | Under Investigation by firm | An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm’s Mayfield Composite Series Base Units and Mayfield Skull C | 5 base units were distributed | 2014-02-21 |
| 2010-05-19 | Not classified | Labeling mix-ups | Storage case incorrectly labeled. The labels were for the Infinity XR2 Skull Clamp storage containers but were inadvertently placed on the Infinity XR2 Base Unit storage cases. | 13 Units | 2011-10-27 |
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.