Integra® Miltex®
Integra® Miltex® Syringe - Petite Aspirating, CW, Purple, Silicone Grips
3manufacturers in China registered for this device type
36catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EJI |
| Device type | Syringe, Cartridge |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6770 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K142414 |
| Record published | 2016-08-03 |
| Record revised | 2026-05-28 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Store suitably packaged and sterilized instruments in a dry, clean, and dust-free environment |
| Sizes | Outer diameter 11 to 12.5 mm; length 15 mm; angle 30 ° |
| Distribution end date | 2022-05-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7770 | 1.8cc | In distribution |
| PN2SS | 2-5/8″ | In distribution |
| PN4 | Outer Diameter 12.5 mm | In distribution |
| 7641 | 1.8cc | In distribution |
| 76100 | 1.8cc | In distribution |
| 76-30 | 1.8cc | In distribution |
| 7670M | 1.8cc | In distribution |
| 7633 | 1.8cc | In distribution |
| PN3SS | Outer Diameter 12 mm | In distribution |
| 7643 | 1.8cc | In distribution |
| 7640 | 1.8cc | In distribution |
| 76-55MSSOB | In distribution | |
| 7642 | In distribution | |
| 7656 | Angle 30 ° | In distribution |
| 76-80 | 1.8cc | In distribution |
| 76-105 | 1.8cc | In distribution |
| 7670 | 1.8cc | In distribution |
| 7632 | In distribution | |
| 76-55SSOB | In distribution | |
| 7690 | 1.8cc | In distribution |
| 7631 | 1.8cc | In distribution |
| 76-55SS | Withdrawn | |
| 76-90M | Withdrawn | |
| 76-32M | Withdrawn | |
| 76-33M | Withdrawn | |
| 76-56M | Withdrawn | |
| 76-55MSS | Withdrawn | |
| 76-80M | Withdrawn | |
| 188-1098 | Withdrawn | |
| 188-2001 | Withdrawn | |
| 76-31M | Withdrawn | |
| 76-42M | Withdrawn | |
| 76-41M | Withdrawn | |
| 76-43M | Withdrawn | |
| 76-30M | Withdrawn | |
| 76-40M | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Septodont | A. Titan Instruments, Inc. | 51 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 46 |
| Astek | Young Innovations Inc. | 34 |
| 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.