Elmed
Goodwin Style Dilation Sounds- shaft with curved tip with flat distal end for curve directional identification and ergonomic sure grip round handle, Complete Set of (10)- consisting of…
Goodwin Style Dilation Sounds- shaft with curved tip with flat distal end for curve directional identification and ergonomic sure grip round handle, Complete Set of (10)- consisting of 12Fr. 14Fr. 16Fr. 18Fr. 20Fr. 22Fr. 24Fr. 26Fr. 28Fr. 30Fr. Autoclavable Medical Grade Stainless Steel.
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Xiamen HOY Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Elmed, Inc., United States |
|---|---|
| FDA product code | KOA |
| Device type | Surgical Instruments, G-U, Manual (And Accessories) |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-04-24 |
| Record revised | 2025-10-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2025-10-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ST31400026 | In distribution | |
| 31534-81 | In distribution | |
| ST3136060 | In distribution | |
| ST315508 | In distribution | |
| ST3154023 | In distribution | |
| 31070-39 39 | In distribution | |
| 31400-43 | In distribution | |
| ST3127056 | In distribution | |
| ST311401011 | In distribution | |
| 31-4000-24 | In distribution | |
| ST3140080 | In distribution | |
| ST3140032 | In distribution | |
| ST315503 | In distribution | |
| 31-4000-30 | In distribution | |
| 31534-33 | In distribution | |
| ST3140021 | In distribution | |
| ST31791001 | In distribution | |
| 51270-16A | In distribution | |
| ST31935014 | In distribution | |
| 31-55-01-01 | In distribution | |
| 30-760 | In distribution | |
| 31-50-01 | In distribution | |
| ST3153431 | In distribution | |
| 51-4080-06 | In distribution | |
| 31340-50 | In distribution | |
| ST31935010 | In distribution | |
| ST3154022 | In distribution | |
| 31-9350-13 | In distribution | |
| 51500-44 | In distribution | |
| ST31791005 | In distribution | |
| 67206-10 | In distribution | |
| 51-4005-22 | In distribution | |
| 31-50-00 | In distribution | |
| ST315504 | In distribution | |
| 51270-16B | In distribution | |
| 30036-180 | In distribution | |
| 51-4005-24 | In distribution | |
| 31560-23SY | In distribution | |
| 31270-56 | In distribution | |
| 31-1401-011 | In distribution | |
| ST314028 | In distribution | |
| 31-2240 | In distribution | |
| ST31400014 | In distribution | |
| 31540-51 | In distribution | |
| 31070-3953 | In distribution | |
| ST30036230 | In distribution | |
| 31-40-28 | In distribution | |
| 51-4005-32 | In distribution | |
| ST3153432 | In distribution | |
| 31-4000-22 | In distribution | |
| 31400-23A | In distribution | |
| 83-31000-CC | In distribution | |
| ST51400510 | In distribution | |
| 31540-23 | In distribution | |
| ST31400022 | In distribution | |
| 31-40-20 | In distribution | |
| 31-55-09 | In distribution | |
| EL-GU8740 | In distribution | |
| ST3156023 | In distribution | |
| 51-4005-12 | In distribution | |
| ST3132851 | In distribution | |
| 31-4000-20 | In distribution | |
| 51-4005-10 | In distribution | |
| 31534-32 | In distribution | |
| ST3153438 | In distribution | |
| 31-40-24 | In distribution | |
| ST3129488 | In distribution | |
| ST31310021 | In distribution | |
| ST51400518 | In distribution | |
| 51-1100 | In distribution | |
| 31-4232 | In distribution | |
| 31534-38 | In distribution | |
| ST314022 | In distribution | |
| 13-CG0823 | In distribution | |
| ST3129486 | In distribution | |
| 51-4230 | In distribution | |
| 31-40-30 | In distribution | |
| ST311401012 | In distribution | |
| 31540-22 | In distribution | |
| 31400-21 | In distribution | |
| 31-A0122.3 | In distribution | |
| ST3174021 | In distribution | |
| ST315000 | In distribution | |
| ST31400012 | In distribution | |
| 31400-32 | In distribution | |
| ST3156022SY | In distribution | |
| ST3132821 | In distribution | |
| ST312240 | In distribution | |
| ST31400016 | In distribution | |
| ST31400024 | In distribution | |
| ST315502 | In distribution | |
| 31560-51 | In distribution | |
| 31-9350-10 | In distribution | |
| 31-9350-11 | In distribution | |
| 51500-33 | In distribution | |
| ST3133432 | In distribution | |
| 31-T1009.1 | In distribution | |
| ST3157060SYRINGE | In distribution | |
| 31-40-26 | In distribution | |
| 31-9350-14 | In distribution | |
| 31-3580-29A3 | In distribution | |
| ST31935012 | In distribution | |
| ST3153481 | In distribution | |
| 31430-01 | In distribution | |
| 31-A3165.7 | In distribution | |
| ST3157814 | In distribution | |
| ST31358029A3 | In distribution | |
| ST31400185 | In distribution | |
| 31-A3166.7 | In distribution | |
| ST31935011 | In distribution | |
| ST30020F70 | In distribution | |
| 31545-02 | In distribution | |
| ST315501 | In distribution | |
| F9922 FS | In distribution | |
| 67206-08 | In distribution | |
| 31791-001 | In distribution | |
| 31791-005 | In distribution | |
| 31570-23 | In distribution | |
| ST31935009 | In distribution | |
| 51-4005-08 | In distribution | |
| 31328-51 | In distribution | |
| ST3156023SY | In distribution | |
| 31-0124 | In distribution | |
| 31-T1001.7 | In distribution | |
| ST13CG0823 | In distribution | |
| ST315505 | In distribution | |
| 30-761 | In distribution | |
| 31300-66A | In distribution | |
| ST310703939 | In distribution | |
| ST3156051 | In distribution | |
| ST315507 | In distribution | |
| 31300-66B | In distribution | |
| 31734-36 | In distribution | |
| 31560-33 | In distribution | |
| ST30036180 | In distribution | |
| ST314024 | In distribution | |
| ST31935008 | In distribution | |
| 31220-32 | In distribution | |
| 31-4000 | In distribution | |
| ST3153451 | In distribution | |
| P31270-00HD-220 | In distribution | |
| 31-50-30 | In distribution | |
| 51-4005-36 | In distribution | |
| ST3154051 | In distribution | |
| 31-4000-18 | In distribution | |
| ST315500 | In distribution | |
| 31-50-05 | In distribution | |
| ST315005 | In distribution | |
| 31-5781-4 | In distribution | |
| 31540-31 | In distribution | |
| 30036-230 | In distribution | |
| ST314030 | In distribution | |
| ST31400028 | In distribution | |
| 31-9350-12 | In distribution | |
| 31360-60 | In distribution | |
| 31-40-18 | In distribution | |
| 51-4005-16 | In distribution | |
| 51-4005-26 | In distribution | |
| 31340-23 | In distribution | |
| 31534-51 | In distribution | |
| ST51400516 | In distribution | |
| ST315509 | In distribution | |
| 31540-21 | In distribution | |
| 31220-22 | In distribution | |
| 51-4005-34 | In distribution | |
| ST315001 | In distribution | |
| 31070-35 35 | In distribution | |
| ST31400020 | In distribution | |
| 51-4005-40 | In distribution | |
| 31-4000-16 | In distribution | |
| 31430-03 | In distribution | |
| 31560-22SY | In distribution | |
| 31740-21 | In distribution | |
| 31-4000-14 | In distribution | |
| 31560-23 | In distribution | |
| 31400-185 | In distribution | |
| 31-40-16 | In distribution | |
| 51-4005-30 | In distribution | |
| 51-4005-28 | In distribution | |
| ST310124 | In distribution | |
| 51-4005-18 | In distribution | |
| ST310703535 | In distribution | |
| ST31400030 | In distribution | |
| ST3157023 | In distribution | |
| 51-4005-14 | In distribution | |
| 31340-20 | In distribution | |
| ST314016 | In distribution | |
| ST319350 | In distribution | |
| ST314020 | In distribution | |
| 31540-20 | In distribution | |
| ST314000 | In distribution | |
| ST310703953 | In distribution | |
| F9924 FS | In distribution | |
| ST31935013 | In distribution | |
| 31570-60-SYRINGE | In distribution | |
| 42-4162-70 | In distribution | |
| 31430-00 | In distribution | |
| ST31400018 | In distribution | |
| 31-2948-6 | In distribution | |
| 31-4000-26 | In distribution | |
| 313100-21 | In distribution | |
| 31400-23B | In distribution | |
| 31400-80 | In distribution | |
| 31-A0121.3 | In distribution | |
| 31340-24 | In distribution | |
| 31-4000-12 | In distribution | |
| ST311401013 | In distribution | |
| ST31550101 | In distribution | |
| 31328-21 | In distribution | |
| 30020F-70 | In distribution | |
| 31-9350 | In distribution | |
| 31334-32 | In distribution | |
| 31-2948-8 | In distribution | |
| ST314018 | In distribution | |
| 31-4000-28 | In distribution | |
| ST314232 | In distribution | |
| 31534-31 | In distribution | |
| 31110-14 | In distribution | |
| 31700-22 | In distribution | |
| ST314026 | In distribution | |
| 31-A3160.7 | In distribution | |
| ST3153433 | In distribution | |
| 31-9350-09 | In distribution | |
| 31-9350-08 | In distribution | |
| ST315506 | In distribution | |
| 51-4005-20 | In distribution | |
| 31340-22 | In distribution | |
| 31-40-22 | In distribution | |
| 31-A3163.7 | In distribution | |
| ST30761 | Withdrawn | |
| 31400-43 | Withdrawn | |
| ST3155TR | Withdrawn | |
| ST30760 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 64 |
| Elmed Incorporated | Elmed, Inc. | 58 |
| Ambler Surgical | Ambler Surgical, LLC | 35 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 33 |
| Cardinal Health | Cardinal Health 200, LLC | 30 |
| Novo Surgical | Novo Surgical, Inc. | 29 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 23 |
| LHB Industries | The Lighthouse For the Blind, Inc. | 15 |
| Zoll-Dental | Zoll-Dental | 13 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 13 |
| Cook | Cook Incorporated | 8 |
| Quinelato | Schobell Industrial Ltda | 7 |
Showing 12 of 74. All products under Surgical Instruments, G-U, Manual (And Accessories)
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.