Integra® Miltex®
Integra® Miltex® Short Bulbous Tip for Metal Ear Syringes (REF # V919-381, V919-383, and V919-385)
24manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (6), Shanghai (4). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Xiamen Betech Trading Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 2 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
| Shanghai Dynamic Medical Supplies Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 37 |
| Ningbo Unico Products Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Essentia Industries Ltd. | Dong Guan | Guangdong | Contract manufacturer | 31 |
| Wenzhou Caretek Medical Device Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 30 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
Showing 12 of 24. All 24 manufacturers in China registered for Syringe, Ent
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | KCP |
| Device type | Syringe, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5220 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-27 |
| Record revised | 2023-11-30 (version 5) |
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 |
| Sizes | Total volume 2 to 4 Fluid Ounce |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V919-381 | Total Volume 2 Fluid Ounce | In distribution |
| V919-383 | Total Volume 3 Fluid Ounce | In distribution |
| V919-394 | In distribution | |
| V919-396 | In distribution | |
| V919-390 | In distribution | |
| V919-385 | Total Volume 4 Fluid Ounce | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LSL Healthcare | Lsl Industries, Inc. | 9 |
| V. Mueller | Steris Corporation | 9 |
| Novo Surgical | Novo Surgical, Inc. | 7 |
| EarClear Rx | Nuance Medical, LLC | 6 |
| mytaMed | Mytamed, Inc. | 6 |
| Bear | Bear-ENT, LLC | 6 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 5 |
| MicroFrance® | Integra Microfrance SAS | 4 |
| BR Surgical, LLC | BR Surgical LLC | 3 |
| Integra® | Integra LifeSciences Production Corporation | 3 |
| Henry Schein | Henry Schein, Inc. | 3 |
| Medi Grade | Ningbo Albert Novosino Co., Ltd. | 2 |
Showing 12 of 59. All products under Syringe, Ent
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.