Osung MND
A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a…
A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. This is a reusable device.
Who Else Makes It
Concentrated in Jiangsu (1), Guangxi (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
Record
| Listed by | Osung MND Co., Ltd., South Korea |
|---|---|
| FDA product code | EJI |
| Device type | Syringe, Cartridge |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6770 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SBA18T3 | In distribution | |
| SAC1 | In distribution | |
| SAA1 | In distribution | |
| SBA18T1 | In distribution | |
| SAB1 | In distribution | |
| SAE1 | In distribution | |
| GMIJ43 | In distribution | |
| GMIJ48 | In distribution | |
| SAF1 | In distribution | |
| SBA18 | In distribution | |
| SBA18T2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Septodont | A. Titan Instruments, Inc. | 51 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 46 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 36 |
| Astek | Young Innovations Inc. | 34 |
| Artman Instruments | Wise Linkers LLC | 16 |
| Safety Wand Handpiece | Milestone Scientific, Inc. | 8 |
| Henke-Dent 500 Soft-Grip | Henke-Sass Wolf, Gmbh. | 8 |
| the Wand STA Handpiece | Milestone Scientific, Inc. | 8 |
| the Wand Handpiece | Milestone Scientific, Inc. | 8 |
| Saftey Wand STA Handpiece | Milestone Scientific, Inc. | 7 |
| J&J Instruments | J & J Instruments, LLC | 6 |
| Patterson | Patterson Dental Supply, Inc. | 4 |
Showing 12 of 88. All products under Syringe, Cartridge
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.