Surgical Direct
5mm 17cm Minimal Incision Cardiovascular, Curved Left TC Needle Holder, Ergonomic Axial Handle with Rachet, Flushport
8manufacturers in China registered for this device type
422catalogue 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 | Surgical Direct, Inc., United States |
|---|---|
| FDA product code | FHQ |
| Device type | Holder, Needle, Gastroenterologic |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-11-30 |
| Record revised | 2025-02-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Distribution end date | 2025-10-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD905679105 | In distribution | |
| SD90508213 | In distribution | |
| SD905589115T | In distribution | |
| SD905151101 | In distribution | |
| SD90511016 | In distribution | |
| SD905700105 | In distribution | |
| SD92208225 | In distribution | |
| SD958513.100 | In distribution | |
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| SD905664100 | In distribution | |
| SD958512.100 | In distribution | |
| SD905605210 | In distribution | |
| SD92208221 | In distribution | |
| SD49185-17 | In distribution | |
| SD90520017 | In distribution | |
| SD90511214 | In distribution | |
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| SD90548120 | In distribution | |
| S5680.104T | In distribution | |
| SD905488104 | In distribution | |
| SD905702020 | In distribution | |
| SD90549016 | In distribution | |
| SD90510016 | In distribution | |
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| SD90547020 | In distribution | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EMI Super Micro Needle Holder | EMI Factory Co., Ltd. | 432 |
| 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 |
| 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.