Integra® Miltex®
Integra® Miltex® House Incudostapedial Joint Knife 6", 0.75mm Diameter Blade, Angled 60°
2manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | JYO |
| Device type | Knife, Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-12-21 |
| Record revised | 2024-03-06 (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 6 in; angle 45 to 60 °; outer diameter 2 to 2.5 mm; width 2 to 3.5 mm; length 3 to 7 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19-510 | In distribution | |
| 19-524 | In distribution | |
| 19-520 | In distribution | |
| 19-512 | 6-1/4″ | In distribution |
| 19-2525 | Angle 60 ° | In distribution |
| 19500 | 6-1/2″ | In distribution |
| 19-2526 | 0.75mm Curved Blade | In distribution |
| 19-505 | 5-7/8″ | In distribution |
| 19-2527 | Length 6 in | In distribution |
| 19-2522 | 6-1/4″ | In distribution |
| 19-2524 | In distribution | |
| 19-502 | 7-1/4″ | In distribution |
| 19-2523 | Length 6 in | In distribution |
| 19-504 | Length 6 in | In distribution |
| 19-506 | 5-7/8″ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 52 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 48 |
| MicroFrance® | Integra Microfrance SAS | 43 |
| V. Mueller | Steris Corporation | 36 |
| Integra® | Integra LifeSciences Production Corporation | 32 |
| Jedmed | Jedmed Instrument Company | 30 |
| HNM Medical | HNM Stainless, LLC. | 29 |
| Inka | The Trustee for Kaiser Family Trust | 23 |
| Ambler Surgical | Ambler Surgical, LLC | 22 |
| Aesculap | Aesculap AG | 21 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 18 |
| Sklar | Sklar Corporation | 14 |
Showing 12 of 41. All products under Knife, Ear
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.