Mondeal
Reusable filter for Sterilisation container L, up to 1000 cleaning & sterilization cycles Ø 190 mm
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.
| 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
| Listed by | Mondeal Medical Systems GmbH, Netherlands |
|---|---|
| FDA product code | FSM |
| Device type | Tray, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2017-06-26 |
| Record revised | 2023-04-04 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2021-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 75-TC3-0677-5 | Withdrawn | |
| 76-TB4-3106 | Withdrawn | |
| 75-TC3-0677-12 | Withdrawn | |
| 75-TC2-0985 | Withdrawn | |
| 75-TC3-0677-125 | Withdrawn | |
| 75-TC3-0677-9 | Withdrawn | |
| 75-TC2-0979 | Withdrawn | |
| 75-TC2-0953 | Withdrawn | |
| 76-TB1-1100 | Withdrawn | |
| 77-TE9-0001 | Withdrawn | |
| 27-TB4-4002 | Withdrawn | |
| 75-TC3-0677-45 | Withdrawn | |
| 75-TC2-0970 | Withdrawn | |
| 75-TC3-0677-7 | Withdrawn | |
| 77-TC1-0948 | Withdrawn | |
| 75-TC3-0677-10 | Withdrawn | |
| 75-TC2-0983 | Withdrawn | |
| 75-TC3-0677-75 | Withdrawn | |
| 76-TB7-2400 | Withdrawn | |
| 27-TB4-1001 | Withdrawn | |
| 75-TC3-0677-2 | Withdrawn | |
| 75-TC3-0677-36 | Withdrawn | |
| 75-TB7-4000 | Withdrawn | |
| 27-TB4-4004 | Withdrawn | |
| 76-TB4-3100 | Withdrawn | |
| 77-TC1-0943 | Withdrawn | |
| 75-TB2-2001 | Withdrawn | |
| 75-TC3-0677-52 | Withdrawn | |
| 27-TB4-4001 | Withdrawn | |
| 75-TC2-0962 | Withdrawn | |
| 75-TC3-0677-95 | Withdrawn | |
| 76-TB4-3105 | Withdrawn | |
| 76-TB1-2100 | Withdrawn | |
| 75-TC2-0965 | Withdrawn | |
| 75-TB1-1001 | Withdrawn | |
| 75-TC2-0949 | Withdrawn | |
| 75-TC3-0677-58 | Withdrawn | |
| 75-TC3-0677-100 | Withdrawn | |
| 77-TG0-0001 | Withdrawn | |
| 77-TC1-0925 | Withdrawn | |
| 75-TC2-0958 | Withdrawn | |
| 75-TC2-0946 | Withdrawn | |
| 77-TA2-2201 | Withdrawn | |
| 77-TC1-0932 | Withdrawn | |
| 27-TA4-1002 | Withdrawn | |
| 77-TA4-2002 | Withdrawn | |
| 75-TC2-0957 | Withdrawn | |
| 27-TA4-1001 | Withdrawn | |
| 75-TC3-0677-48 | Withdrawn | |
| 75-TC2-0942 | Withdrawn | |
| 75-TC2-0960 | Withdrawn | |
| 75-TC2-0950 | Withdrawn | |
| 75-TC3-0677-16 | Withdrawn | |
| 27-TB4-2001 | Withdrawn | |
| 76-TB2-2000 | Withdrawn | |
| 77-TC1-0923 | Withdrawn | |
| 27-TC1-0923M1 | Withdrawn | |
| 27-TC1-0922M2 | Withdrawn | |
| 75-TC2-0973 | Withdrawn | |
| 75-TC2-0968 | Withdrawn | |
| 75-TC3-0677-115 | Withdrawn | |
| 75-TC3-0677-70 | Withdrawn | |
| 75-TC3-0677-13 | Withdrawn | |
| 75-TA2-1001 | Withdrawn | |
| 77-TA4-2001 | Withdrawn | |
| 76-TB4-3108 | Withdrawn | |
| 75-TC2-0986 | Withdrawn | |
| 75-TC3-0677-40 | Withdrawn | |
| 77-TC1-0944 | Withdrawn | |
| 75-TC2-0984 | Withdrawn | |
| 75-TC3-0677-46 | Withdrawn | |
| 75-TC2-0963 | Withdrawn | |
| 27-TC1-0923M3 | Withdrawn | |
| 75-TC3-0677-32 | Withdrawn | |
| 75-TC2-0982 | Withdrawn | |
| 77-KT1-001 | Withdrawn | |
| 75-TC3-0677-22 | Withdrawn | |
| 75-TC3-0677-90 | Withdrawn | |
| 75-TC3-0677-4 | Withdrawn | |
| 75-TC3-0677-55 | Withdrawn | |
| 75-TC2-0943 | Withdrawn | |
| 76-TB4-3101 | Withdrawn | |
| 77-TC1-0945 | Withdrawn | |
| 77-TG0-0002 | Withdrawn | |
| 77-TC1-0901 | Withdrawn | |
| 75-TC3-0677-15 | Withdrawn | |
| 75-TB2-1001 | Withdrawn | |
| 75-TC3-0677-24 | Withdrawn | |
| 27-TB4-4003 | Withdrawn | |
| 75-TC3-0677-6 | Withdrawn | |
| 77-TC1-0930 | Withdrawn | |
| 75-TC3-0677-140 | Withdrawn | |
| 75-TC2-0941 | Withdrawn | |
| 77-TC1-0934 | Withdrawn | |
| 27-TC1-0923M2 | Withdrawn | |
| 27-TC1-0922M1 | Withdrawn | |
| 75-TC3-0677-120 | Withdrawn | |
| 75-TC2-0947 | Withdrawn | |
| 76-TB4-3102 | Withdrawn | |
| 77-TC1-0931 | Withdrawn | |
| 75-TC3-0677-14 | Withdrawn | |
| 75-TC3-0677-11 | Withdrawn | |
| 27-TB5-2002 | Withdrawn | |
| 27-TB4-4005 | Withdrawn | |
| 27-TB5-2004 | Withdrawn | |
| 75-TC3-0677-3 | Withdrawn | |
| 77-TC1-0941 | Withdrawn | |
| 75-TC2-0975 | Withdrawn | |
| 75-TC3-0677-34 | Withdrawn | |
| 75-TB1-1002 | Withdrawn | |
| 75-TC2-0974 | Withdrawn | |
| 76-TB7-3400 | Withdrawn | |
| 76-TB4-3103 | Withdrawn | |
| 76-TB7-2200 | Withdrawn | |
| 75-TC3-0677-65 | Withdrawn | |
| 75-TC2-0952 | Withdrawn | |
| 75-TC3-0677-28 | Withdrawn | |
| 27-TB5-1002 | Withdrawn | |
| 75-TC3-0677-38 | Withdrawn | |
| 75-TC3-0677-60 | Withdrawn | |
| 75-TC2-0961 | Withdrawn | |
| 75-TC2-0971 | Withdrawn | |
| 77-TC1-0940 | Withdrawn | |
| 76-TB6-3401 | Withdrawn | |
| 75-TC2-0966 | Withdrawn | |
| 75-TC2-0969 | Withdrawn | |
| 27-TB5-2003 | Withdrawn | |
| 27-TA4-1003 | Withdrawn | |
| 75-TC2-0972 | Withdrawn | |
| 75-TB4-4001 | Withdrawn | |
| 75-TC3-0677-105 | Withdrawn | |
| 77-TA1-2001 | Withdrawn | |
| 75-TC2-0944 | Withdrawn | |
| 77-TA1-3001 | Withdrawn | |
| 75-TC3-0677-54 | Withdrawn | |
| 75-TC3-0677-50 | Withdrawn | |
| 27-TB4-1002 | Withdrawn | |
| 77-TC1-0924 | Withdrawn | |
| 75-TC3-0677-130 | Withdrawn | |
| 77-TC1-0926 | Withdrawn | |
| 77-TC1-0942 | Withdrawn | |
| 75-TC3-0677-8 | Withdrawn | |
| 27-TB5-4001 | Withdrawn | |
| 75-TC3-0677-42 | Withdrawn | |
| 76-TB7-3200 | Withdrawn | |
| 75-TC3-0677-110 | Withdrawn | |
| 75-TA1-1001 | Withdrawn | |
| 76-TB6-3402 | Withdrawn | |
| 77-TE7-2001 | Withdrawn | |
| 27-TC1-0921 | Withdrawn | |
| 75-TC2-0977 | Withdrawn | |
| 75-TC2-0945 | Withdrawn | |
| 77-TC1-0922 | Withdrawn | |
| 75-TC2-0959 | Withdrawn | |
| 27-TC1-0922M4 | Withdrawn | |
| 75-TC3-0677-85 | Withdrawn | |
| 75-TC3-0677-18 | Withdrawn | |
| 75-TC3-0677-135 | Withdrawn | |
| 75-TC2-0981 | Withdrawn | |
| 76-TB6-3400 | Withdrawn | |
| 76-TB4-3104 | Withdrawn | |
| 75-TC3-0677-30 | Withdrawn | |
| 77-TC1-0935 | Withdrawn | |
| 77-TC1-0933 | Withdrawn | |
| 77-TC1-0936 | Withdrawn | |
| 75-TC3-0677-44 | Withdrawn | |
| 77-TC1-0937 | Withdrawn | |
| 77-TA4-3002 | Withdrawn | |
| 75-TF1-1002 | Withdrawn | |
| 75-TC3-0677-80 | Withdrawn | |
| 27-TB5-2001 | Withdrawn | |
| 27-TB5-1001 | Withdrawn | |
| 75-TC2-0964 | Withdrawn | |
| 75-TB7-2001 | Withdrawn | |
| 76-TB4-3107 | Withdrawn | |
| 77-TC1-0947 | Withdrawn | |
| 75-TB7-4001 | Withdrawn | |
| 75-TC3-0677-20 | Withdrawn | |
| 75-TC3-0677-25 | Withdrawn | |
| 77-TC1-0921 | Withdrawn | |
| 75-TC3-0677-26 | Withdrawn | |
| 75-TC3-0677-35 | Withdrawn | |
| 77-TA4-3001 | Withdrawn | |
| 27-TC1-0922M3 | Withdrawn | |
| 75-TC2-0967 | Withdrawn | |
| 76-TB4-3109 | Withdrawn | |
| 77-TE7-2002 | Withdrawn | |
| 77-TC1-0946 | Withdrawn | |
| 77-TC1-0920 | Withdrawn | |
| 75-TC3-0677-56 | Withdrawn |
Same 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.