Stoma®
Micro-needle-holder, Zucchelli, TC, ultra fine, 0,5mm, straight, smooth, 18cm, hy-light
32manufacturers in China registered for this device type
63catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (11), Zhejiang (8), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Wanying Health & Technology (Zhongshan) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 3 |
| Zhejiang Solong Electromechanical Limited | Pujiang | Zhejiang | Contract manufacturer | 3 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
Showing 12 of 32. All 32 manufacturers in China registered for Guide, Needle, Surgical
Record
| Listed by | Storz AM Mark Gmbh, Germany |
|---|---|
| FDA product code | GDF |
| Device type | Guide, Needle, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-27 |
| Record revised | 2021-01-08 (version 2) |
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 |
|---|---|---|
| 4702.13 | In distribution | |
| 14755.48 | In distribution | |
| 4704.18 | In distribution | |
| 14745.28 | In distribution | |
| 14761.18 | In distribution | |
| 14758.18 | In distribution | |
| 4724.16 | In distribution | |
| 14747.15 | In distribution | |
| 4725.17 | In distribution | |
| 14751.18 | In distribution | |
| 4707.12 | In distribution | |
| 14758.15 | In distribution | |
| 4724.18 | In distribution | |
| 14759.15 | In distribution | |
| 4719.12 | In distribution | |
| 4723.17 | In distribution | |
| 14748.18 | In distribution | |
| 14749.18 | In distribution | |
| 4723.14 | In distribution | |
| 4701.14 | In distribution | |
| 4701.17 | In distribution | |
| 4706.18 | In distribution | |
| 4720.16 | In distribution | |
| 4740.17 | In distribution | |
| 14760.18 | In distribution | |
| 4725.14 | In distribution | |
| 4719.16 | In distribution | |
| 14745.18 | In distribution | |
| 14750.48 | In distribution | |
| 4760.15 | In distribution | |
| 14749.15 | In distribution | |
| 4739.17 | In distribution | |
| 4709.16 | In distribution | |
| 4710.18 | In distribution | |
| 14761.48 | In distribution | |
| 14760.48 | In distribution | |
| 14746.15 | In distribution | |
| 14751.15 | In distribution | |
| 4706.15 | In distribution | |
| 4742.17 | In distribution | |
| 4709.18 | In distribution | |
| 4706.13 | In distribution | |
| 14745.15 | In distribution | |
| 4720.14 | In distribution | |
| 4724.20 | In distribution | |
| 4712.00 | In distribution | |
| 4705.13 | In distribution | |
| 14746.18 | In distribution | |
| 4741.17 | In distribution | |
| 4703.13 | In distribution | |
| 14750.18 | In distribution | |
| 14762.48 | In distribution | |
| 14751.48 | In distribution | |
| 4708.18 | In distribution | |
| 4743.17 | In distribution | |
| 14748.15 | In distribution | |
| 4708.14 | In distribution | |
| 4715.13 | In distribution | |
| 14744.18 | In distribution | |
| 4714.00 | In distribution | |
| 4738.17 | In distribution | |
| 4719.14 | In distribution | |
| 4710.15 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Needle Holder | Koros U.S.A., Inc. | 175 |
| Aptus | Medartis Inc. | 62 |
| Philips | Philips Medical Systems Nederland B.V. | 31 |
| Temno | Carefusion 2200, Inc. | 31 |
| MaxMoreSpine | Hoogland Spine Products GmbH | 23 |
| Silex Sacroiliac Joint Fusion System | Xtant Medical Holdings, Inc. | 20 |
| Biopsybell | Biopsybell SRL | 16 |
| Arterial Needle | Argon Medical Devices, Inc. | 14 |
| Ghiatas® | Bard Peripheral Vascular, Inc. | 14 |
| Sklar® | Sklar Corporation | 14 |
| Leap Med | Advance Medical Designs, Inc. | 14 |
| Gimmi | Gimmi Gmbh | 11 |
Showing 12 of 169. All products under Guide, Needle, Surgical
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.