Integra® Miltex®
Integra® Miltex® Dix Foreign Body Needle/Spud, protected in reversible screw handle
4manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | HNA |
| Device type | Spud, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-06-28 |
| Record revised | 2024-11-19 (version 8) |
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 | Length 23.8 to 27 mm; width 1.3 to 1.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18-304 | 2mm blade | In distribution |
| 18-402B | In distribution | |
| 18-302 | In distribution | |
| 18-301 | In distribution | |
| 18-384 | 1.0mm | In distribution |
| 18400 | In distribution | |
| 18-390 | In distribution | |
| 18-374 | Width 1.6 mm | In distribution |
| 18-380 | 4-1/2″ | In distribution |
| 18-372 | In distribution | |
| 18-402 | In distribution | |
| 18-388 | Length 23.8 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Jarit® | Integra LifeSciences Production Corporation | 14 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 13 |
| Ambler Surgical | Ambler Surgical, LLC | 12 |
| Stephens Instruments | Krishna Imports Inc | 7 |
| Spud, Ophthalmic | Geuder Aktiengesellschaft | 5 |
| Spud | Katena Products, Inc. | 5 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 3 |
| Phaco Chopper | Sontec Instruments, Inc. | 3 |
| Pilling | Teleflex Medical LLC | 3 |
| Nagahara Chopper | Sontec Instruments, Inc. | 3 |
| Intracapular Manipulating Wand | Sontec Instruments, Inc. | 3 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 3 |
Showing 12 of 59. All products under Spud, Ophthalmic
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.