TSI
Straight Articulating ARM, Long, Instrument Holder
25manufacturers in China registered for this device type
87catalogue 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.
| 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 | Tedan Surgical Innovations, L.L.C. |
|---|---|
| FDA product code | FWZ |
| Device type | Operating Room Accessories Table Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4950 |
| Premarket notification | Exempt |
| Record published | 2017-08-22 |
| Record revised | 2020-09-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 16.5 to 42 cm |
| Distribution end date | 2023-09-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ML-0025 | In distribution | |
| ML-0063 | In distribution | |
| ML-0901 | In distribution | |
| BW-0420 | In distribution | |
| UL-0110 | In distribution | |
| ML-0043 | In distribution | |
| CT-0320 | In distribution | |
| TK-0605 | In distribution | |
| TK-0104 | In distribution | |
| TK-0150 | In distribution | |
| HS-0016 | In distribution | |
| AL-0100 | In distribution | |
| AL-0101 | In distribution | |
| AL-0110 | In distribution | |
| HS-0110 | In distribution | |
| TK-0101 | Length 38 cm | In distribution |
| VPR0021 | In distribution | |
| TK-0102 | Length 42 cm | In distribution |
| ML-0040 | In distribution | |
| AL-0107 | In distribution | |
| ML-0038 | In distribution | |
| ML-0034 | In distribution | |
| ML-0021 | In distribution | |
| AL-0103 | In distribution | |
| TK-0312 | In distribution | |
| TK-0103 | Length 16.5 cm | In distribution |
| ML-0022 | In distribution | |
| TK-0620 | In distribution | |
| UL-0101 | In distribution | |
| TK-0210 | In distribution | |
| ML-0037 | In distribution | |
| ML-0060 | In distribution | |
| TK-0107 | In distribution | |
| TK-0300 | In distribution | |
| UL-0106 | In distribution | |
| TK-0152 | In distribution | |
| TK-0604 | In distribution | |
| UL-0100 | In distribution | |
| HS-0305 | In distribution | |
| ML-0026 | In distribution | |
| ML-0061 | In distribution | |
| VPR0060 | In distribution | |
| TK-0200 | In distribution | |
| ML-0023 | In distribution | |
| HS-0100 | In distribution | |
| TK-0601 | In distribution | |
| ML-0027 | In distribution | |
| ML-0024 | In distribution | |
| TK-0650 | In distribution | |
| UL-0103 | In distribution | |
| TK-0602 | In distribution | |
| TK-0308 | In distribution | |
| HS-0019 | In distribution | |
| TK-0316 | In distribution | |
| ML-0057 | In distribution | |
| ML-0902 | In distribution | |
| ML-0020 | In distribution | |
| TK-0105 | In distribution | |
| CT-0105 | In distribution | |
| TK-0310 | In distribution | |
| BW-0422 | In distribution | |
| UL-0116 | In distribution | |
| BW-0404 | In distribution | |
| HS-0005 | In distribution | |
| TK-0106 | In distribution | |
| TK-0314 | In distribution | |
| UL-0102 | In distribution | |
| ML-0044 | In distribution | |
| ML-0041 | In distribution | |
| BW-0015 | Withdrawn | |
| HS-0024 | Withdrawn | |
| HS-0060 | Withdrawn | |
| HS-0115 | Withdrawn | |
| ML-0902 | Withdrawn | |
| CT-0308 | Withdrawn | |
| BW-0025 | Withdrawn | |
| HS-0030 | Withdrawn | |
| BW-0304 | Withdrawn | |
| BW-0312 | Withdrawn | |
| HS-0062 | Withdrawn | |
| HS-0050 | Withdrawn | |
| ML-0056 | Withdrawn | |
| HS-0040 | Withdrawn | |
| HS-0015 | Withdrawn | |
| HS-0045 | Withdrawn | |
| ML-0039 | Withdrawn | |
| HS-0035 | 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 |
| 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
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.