Astek
inSafe Syringe, 1.8ml, 3?Point Harpoon Asp., Thum Ring ? Astek
3manufacturers in China registered for this device type
34catalogue numbers in this listing
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 | Young Innovations Inc., United States |
|---|---|
| FDA product code | EJI |
| Device type | Syringe, Cartridge |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6770 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-12-01 |
| Record revised | 2025-05-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Package, case, package of 250, case of 25 |
| Distribution end date | 2025-08-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 23014ASTEK3KITM | In distribution | |
| 23008ASTEK | In distribution | |
| 23009ASTEK3KITM | In distribution | |
| 23008ASTEK3KITM | In distribution | |
| 23005ASTEK3KITM | In distribution | |
| 23009ASTEK | In distribution | |
| 23012ASTEK | Withdrawn | |
| 23015ASTEK3KIT | Withdrawn | |
| 23004ASTEK | Withdrawn | |
| 23014ASTEK3KIT | Withdrawn | |
| 23005ASTEK | Withdrawn | |
| 23044ASTEK | Withdrawn | |
| 23016ASTEK3KIT | Withdrawn | |
| 23014ASTEK | Withdrawn | |
| 23060ASTEK | Withdrawn | |
| 23007ASTEK | Withdrawn | |
| 23006ASTEK | Withdrawn | |
| 23011ASTEK3KIT | Withdrawn | |
| 23001ASTEK | Withdrawn | |
| 23003ASTEK | Withdrawn | |
| 23004ASTEK3KITM | Withdrawn | |
| 23044ASTEK | Withdrawn | |
| 23013ASTEK | Withdrawn | |
| 23015ASTEK | Withdrawn | |
| 23050ASTEK | Withdrawn | |
| 23011ASTEK | Withdrawn | |
| 23046ASTEK | Withdrawn | |
| 23002ASTEK | Withdrawn | |
| 23012ASTEK3KIT | Withdrawn | |
| 23013ASTEK3KIT | Withdrawn | |
| 23017ASTEK | Withdrawn | |
| 23002ASTEK3KITM | Withdrawn | |
| 23016ASTEK | Withdrawn | |
| 23046ASTEK | Withdrawn |
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 |
| Artman Instruments | Wise Linkers LLC | 16 |
| Osung MND | Osung MND Co., Ltd. | 11 |
| 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.