Integra® Miltex®
Integra® Miltex® Castroviejo Needle Holder 5-5/8", Tungsten Carbide, Straight, Smooth Jaws, Serrated Handle with Lock
8manufacturers in China registered for this device type
211catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (5), 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 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | FHQ |
| Device type | Holder, Needle, Gastroenterologic |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-06-28 |
| Record revised | 2024-03-06 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do Not use if package is damaged |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 17-980 | In distribution | ||
| 8-5TC | In distribution | ||
| 8-51 | 7-1/4″ | In distribution | |
| MH8-22 | In distribution | ||
| 8-83TC | In distribution | ||
| MH8-14 | In distribution | ||
| MH8-130 | In distribution | ||
| EG8-16 | 12 | In distribution | |
| EG8-42 | 12 | In distribution | |
| 8-81TC | In distribution | ||
| V98-6 | In distribution | ||
| MH8-48 | In distribution | ||
| 8-134 | 10-3/4″ | In distribution | |
| 8-4 | In distribution | ||
| MH8-16 | In distribution | ||
| 181828TC | In distribution | ||
| MH8-16TC | In distribution | ||
| PM-2325 | In distribution | ||
| MH8-40 | In distribution | ||
| MH8-42TC | In distribution | ||
| 8-114 | In distribution | ||
| 8-15TC | In distribution | ||
| PM-2410 | In distribution | ||
| V98-42 | In distribution | ||
| PM-2170 | In distribution | ||
| 8-28 | In distribution | ||
| MH8-17TC | In distribution | ||
| MH8-104TC | In distribution | ||
| 8-82TC | 8-1/4″ | In distribution | |
| 8-96TC | In distribution | ||
| 8-14 | In distribution | ||
| 8-32 | In distribution | ||
| 8-26 | 4-7/8″ Length | In distribution | |
| 8-136 | 10-1/2″ | In distribution | |
| 8-30 | In distribution | ||
| 8-55TC | In distribution | ||
| PM-2415 | In distribution | ||
| MH8-52TC | In distribution | ||
| MH8-130TC | 10-1/2″ Length | In distribution | |
| PM-2145 | In distribution | ||
| PM-2350 | In distribution | ||
| PM-3710 | In distribution | ||
| 8-7A-TC | In distribution | ||
| 8-750TC | In distribution | ||
| MH8-101TC | In distribution | ||
| 8-748TC | In distribution | ||
| MH8-6 | 4-7/8″ | In distribution | |
| PM-2160 | In distribution | ||
| MH8-44 | In distribution | ||
| MH8-4TC | In distribution | ||
| 8-53 | In distribution | ||
| MH8-42 | In distribution | ||
| 18-1839 | In distribution | ||
| 8-14A-TC | In distribution | ||
| 8-42 | In distribution | ||
| MH8-20 | In distribution | ||
| PM-2435 | In distribution | ||
| 17-1010 | In distribution | ||
| MH8-103TC | In distribution | ||
| 8-2 | In distribution | ||
| PM-2406 | In distribution | ||
| 8-62TC | 5-7/8″ | In distribution | |
| 8-6TC | In distribution | ||
| 8-100 | In distribution | ||
| 8-17 | In distribution | ||
| 8-105TC | In distribution | ||
| 8-753TC | In distribution | ||
| PM-3160 | 5-3/4″ | In distribution | |
| 8-746TC | In distribution | ||
| 8-40 | In distribution | ||
| V98-17 | In distribution | ||
| MH8-50 | In distribution | ||
| 181837 | 4-1/8″ | In distribution | |
| V98-15 | In distribution | ||
| 8-48 | In distribution | ||
| 17-1024 | In distribution | ||
| 8-52TC | In distribution | ||
| 8-751TC | In distribution | ||
| 8-100TC | In distribution | ||
| 18-1828A-TC | In distribution | ||
| V98-16 | In distribution | ||
| ST8-6 | 50 | In distribution | |
| PM-2445 | In distribution | ||
| MH18-1832 | In distribution | ||
| 8-40TC | In distribution | ||
| 18-1820 | In distribution | ||
| 8-106TC | In distribution | ||
| 8-130 | In distribution | ||
| PM-2420 | In distribution | ||
| 18-1831 | 5-3/4″ | In distribution | |
| 8-8A-TC | In distribution | ||
| 8-94 | In distribution | ||
| MH8-2 | In distribution | ||
| 8-28TC | 5-1/2″ | In distribution | |
| V98-2 | In distribution | ||
| MH8-50TC | In distribution | ||
| 8-752TC | In distribution | ||
| 8-52 | In distribution | ||
| PM-2321 | In distribution | ||
| ST8-44 | 50 | In distribution | |
| 18-1833 | 5-3/4″ | In distribution | |
| V918-1828 | In distribution | ||
| MH8-46TC | In distribution | ||
| V98-46 | In distribution | ||
| ST8-50 | 50 | In distribution | |
| MH8-100TC | In distribution | ||
| 8-42TC | In distribution | ||
| PM-2405 | 4-5/8″ | In distribution | |
| 8-44 | In distribution | ||
| 8-101TC | In distribution | ||
| 8-30TC | In distribution | ||
| 18-1840 | In distribution | ||
| 17-1020 | In distribution | ||
| MH8-40TC | In distribution | ||
| 8-104TC | In distribution | ||
| 171000 | In distribution | ||
| 8-51TC | In distribution | ||
| 8-44TC | In distribution | ||
| MH8-48TC | In distribution | ||
| 8-46 | 7-1/2″ | In distribution | |
| 8-107TC | In distribution | ||
| 8-17TC | In distribution | ||
| V98-28 | In distribution | ||
| 8-46TC | In distribution | ||
| 8-14TC | In distribution | ||
| 18-1832A-TC | 5-1/2″ | In distribution | |
| PM-2440 | In distribution | ||
| 8-8TC | In distribution | ||
| PM-2206 | 5-7/8″ | In distribution | |
| 8-63TC | In distribution | ||
| V98-50 | In distribution | ||
| MH8-15TC | In distribution | ||
| MH8-52 | In distribution | ||
| EG8-44 | 12 | In distribution | |
| 8-57TC | In distribution | ||
| 8-15 | In distribution | ||
| 8-49TC | In distribution | ||
| MH8-51TC | In distribution | ||
| 8-744TC | In distribution | ||
| EG8-17 | 12 | In distribution | |
| V98-44 | In distribution | ||
| 8-102 | In distribution | ||
| 8-48TC | In distribution | ||
| 8-76 | 7-1/4″ | In distribution | |
| V98-48 | In distribution | ||
| PM-3715 | In distribution | ||
| 18-1828 | In distribution | ||
| MH8-6TC | In distribution | ||
| 8-7 | In distribution | ||
| 8-50TC | In distribution | ||
| PM-2415LH | In distribution | ||
| PM-3720 | In distribution | ||
| 8-69TC | In distribution | ||
| PM-2130 | In distribution | ||
| V98-40 | In distribution | ||
| MH8-46 | In distribution | ||
| 8-134TC | In distribution | ||
| 8-53TC | In distribution | ||
| 17-1025 | In distribution | ||
| 18-1816TC | In distribution | ||
| V98-4 | In distribution | ||
| 18-1824 | In distribution | ||
| PM-2200 | In distribution | ||
| 181832 | In distribution | ||
| 8-130TC | In distribution | ||
| PM-2320 | In distribution | ||
| MH8-51 | In distribution | ||
| 8-16TC | In distribution | ||
| PM-2110 | In distribution | ||
| 8-8 | In distribution | ||
| EG8-6 | 12 | In distribution | |
| 8-58 | In distribution | ||
| 8-16 | In distribution | ||
| MH8-4 | In distribution | ||
| 8-7TC | In distribution | ||
| 8-14A | In distribution | ||
| 8-59 | In distribution | ||
| MH8-15 | In distribution | ||
| 8-66TC | In distribution | ||
| V98-8 | In distribution | ||
| MH8-100 | In distribution | ||
| 8D-36 | In distribution | ||
| 8-50A-TC | In distribution | ||
| 8-114TC | In distribution | ||
| 8-6 | In distribution | ||
| MH18-1828 | In distribution | ||
| MH8-44TC | In distribution | ||
| 18-1832TC | 5-3/4″ | In distribution | |
| 8-103TC | 5-7/8″ | In distribution | |
| MH8-17 | In distribution | ||
| MH8-8A-TC | In distribution | ||
| MH8-8 | In distribution | ||
| 8-706TC | In distribution | ||
| 8-3TC | In distribution | ||
| PM-2400 | In distribution | ||
| MH18-1828TC | In distribution | ||
| 181838 | In distribution | ||
| PM-2430 | In distribution | ||
| 8-4TC | In distribution | ||
| 8-50 | In distribution | ||
| 8-102TC | In distribution | ||
| 18-1854 | Withdrawn | ||
| 18-1852 | Withdrawn | ||
| 8-84 | Withdrawn | ||
| 8-4CG | Withdrawn | ||
| 18-1863 | Withdrawn | ||
| 18-1864 | Withdrawn | ||
| 18-1850 | Withdrawn | ||
| 18-1834 | Withdrawn | ||
| 18-1857 | Withdrawn | ||
| 18-1853 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EMI Super Micro Needle Holder | EMI Factory Co., Ltd. | 432 |
| Surgical Direct | Surgical Direct, Inc. | 422 |
| Peak Medical | Peak Medical Distribution Inc | 406 |
| Novo Surgical | Novo Surgical, Inc. | 312 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 293 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 235 |
| HNM Medical | HNM Stainless, LLC. | 225 |
| Scanlan® Needle Holders | Scanlan International, Inc. | 192 |
| Hayden Medical | Hayden Medical Inc | 191 |
| Jacobson Needle Holder | Sontec Instruments, Inc. | 173 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 164 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 161 |
Showing 12 of 455. All products under Holder, Needle, Gastroenterologic
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.