Black & Black Surgical, Inc.
Stratte Onyx Needle Holder; 9"'(23CM), TC, 4000 JAW
8manufacturers in China registered for this device type
1catalogue number
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 | Black & Black Surgical, Inc., United States |
|---|---|
| FDA product code | FHQ |
| Device type | Holder, Needle, Gastroenterologic |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-04-15 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B50250 | 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.