Needle, Neurosurgical Suture
Raptor Suture Passer Needle
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
Record
| Listed by | Doppkon Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | HAS |
| Device type | Needle, Neurosurgical Suture |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4650 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-12-04 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A-100-520 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 5 |
| Avalign | Avalign Technologies, Inc. | 3 |
| Symmetry Rhoton® | Aspen Surgical Products, Inc. | 2 |
| Millennium | Avalign Technologies, Inc. | 2 |
| Pilling | Teleflex Medical LLC | 1 |
| Symmetry Adson | Aspen Surgical Products, Inc. | 1 |
| V. Mueller | Steris Corporation | 1 |
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.