AED ETH1592-RN Romeo Needle Holder, 5mm X 33cm
A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal…
A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle.
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 | National Advanced Endoscopy Devices, Inc., 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, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-05-18 |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ETH1592-RN | In distribution |
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 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 211 |
| 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 |
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.