Symmetry Surgical
Ultra Instruments® Needle, Cone Biopsy, Blunt Obturator Luer Lock, Sharp Open End, 13G
4manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Beijing (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 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Hotry Co., Ltd. | Beijing | Beijing | Manufacturer | 9 |
Record
| Listed by | Aspen Surgical Products, Inc., United States |
|---|---|
| FDA product code | HAO |
| Device type | Instrument, Surgical, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4535 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-07 |
| Record revised | 2025-10-29 (version 6) |
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 |
| Sizes | Length 3.5 to 8 in; width 6 to 13 mm; length 45 to 85 mm; angle 90 °; needle gauge 12 G |
| Distribution end date | 2024-07-22 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 26-2774 | Length 7.75 in | In distribution |
| 57-0003 | Width 11 mm | In distribution |
| 57-5038 | Length 8 in | In distribution |
| 45-1010 | In distribution | |
| 45-1022 | In distribution | |
| 57-7731 | Length 3.5 in | In distribution |
| 45-1013 | In distribution | |
| 57-5651-85 | Length 85 mm | In distribution |
| 57-0001 | Width 6 mm | In distribution |
| 57-7732 | Length 3.5 in | In distribution |
| 45-1016 | In distribution | |
| 58-7576 | Length 8 in | In distribution |
| 57-7736 | Length 3.5 in | In distribution |
| 57-5649 | Length 55 mm | In distribution |
| 57-5648 | Length 50 mm | In distribution |
| 20-2059 | Width 9 mm | In distribution |
| 57-5647 | Length 45 mm | In distribution |
| 57-5699 | In distribution | |
| 57-0004 | Width 13 mm | In distribution |
| 45-1024 | In distribution | |
| 28-4406 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 705 |
| Ambler Surgical | Ambler Surgical, LLC | 597 |
| V. Mueller | Steris Corporation | 577 |
| Millennium | Avalign Technologies, Inc. | 383 |
| Avalign | Avalign Technologies, Inc. | 352 |
| Novo Surgical | Novo Surgical, Inc. | 300 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 283 |
| Boss Instruments | Boss Instruments, Ltd. | 263 |
| Pilling | Teleflex Medical LLC | 156 |
| Instrument, Surgical, Non-Powered | Karl Storz GmbH & Co. KG | 130 |
| Instrument, Surgical, Non-Powered | Fehling Instruments GmbH | 126 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 109 |
Showing 12 of 249. All products under Instrument, Surgical, Non-Powered
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.