Elmed Incorporated
Elmed Continuous Flow Operating Sheath, 7MM DIA., With Instrument Channel; Consisting OF: (1) 51400-16A - 5FR Examination Sheath, (1) 51400-16B 7MM Outer Sheath, (1) 51400-16C Obturator
5manufacturers in China registered for this device type
58catalogue numbers in this listing
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 | 2025-04-15 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31-50-50 | In distribution | |
| 31300-61 | In distribution | |
| 31540-24 | In distribution | |
| 31540-91 | In distribution | |
| 31-50-15 | In distribution | |
| 31-2235 | In distribution | |
| ST42416270 | In distribution | |
| 30036-70 | In distribution | |
| 31540-81 | In distribution | |
| 31070-39-08 | In distribution | |
| ST5150033 | In distribution | |
| 31-50-10 | In distribution | |
| ST3154033 | In distribution | |
| 31565-23 | In distribution | |
| 51400-16 | In distribution | |
| 51-4080-08 | In distribution | |
| 51270-16 | In distribution | |
| 31555-50 | In distribution | |
| 31370-05 | In distribution | |
| 51500-38 | In distribution | |
| ST51400508 | In distribution | |
| 31700-34 | In distribution | |
| 31540-33 | In distribution | |
| ST3154036 | In distribution | |
| 31960-36 | In distribution | |
| ST3154081 | In distribution | |
| 31560-21 | In distribution | |
| 31400-61 | In distribution | |
| ST310128 | In distribution | |
| ST514230 | In distribution | |
| 31934-21 | In distribution | |
| 31934-41 | In distribution | |
| 31400-57 | In distribution | |
| 51-3401-24.5 | In distribution | |
| 31560-60 | In distribution | |
| 51400-16C | In distribution | |
| ST311528 | In distribution | |
| 31070-35-08 | In distribution | |
| 31112-32 | In distribution | |
| 31540-61 | In distribution | |
| 31960-63 | In distribution | |
| 31400-85 | In distribution | |
| 4578 | In distribution | |
| 31740-22 | In distribution | |
| 31430-06 | In distribution | |
| 31430-02 | In distribution | |
| 51400-16A | In distribution | |
| 31-50-20 | In distribution | |
| 31400-56 | In distribution | |
| 12-330P25564 | In distribution | |
| 31635-01 | In distribution | |
| 31430-00B | In distribution | |
| 30670-28 | In distribution | |
| 31-882-240 | In distribution | |
| 31960-31 | In distribution | |
| 31560-50 | In distribution | |
| 51400-16B | In distribution | |
| 31560-22 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed | Elmed, Inc. | 233 |
| Millennium | Avalign Technologies, Inc. | 64 |
| 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.