Disc Preparation Instruments
Suction Tube Retractor Stylet
3manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shenzhen Xinzhengyu Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | GAH |
| Device type | Stylet, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-12-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 142M5112 | Device Size Text, specify—Suction Tube Stylet 12F | In distribution |
| 142M5108 | Device Size Text, specify—Suction Tube Stylet 8F | In distribution |
| 142M1100 | Device Size Text, specify—Suction Tube Retractor Stylet | In distribution |
| 142M5110 | Device Size Text, specify—Suction Tube Stylet 10F | In distribution |
| 142M2100 | Device Size Text, specify—Suction Retractor Stylet | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lion | Hans Biomed Corp. | 17 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 9 |
| Orthopediatrics Instrumentation | Orthopediatrics, Corp | 7 |
| Summa Orthopaedics System Surgical Instrument | Jeil Medical Corporation | 6 |
| Surgical Instrument | Jeil Medical Corporation | 6 |
| OrthoPediatrics Cannulated Screw System | Orthopediatrics, Corp | 6 |
| Osseoflex® | Merit Medical Systems, Inc. | 6 |
| Inlet System Surgical Instrument | Jeil Medical Corporation | 5 |
| Symmetry Frazier | Aspen Surgical Products, Inc. | 5 |
| Visualase | Medtronic Navigation, Inc. | 5 |
| Prometheus System Surgical Instrument | Jeil Medical Corporation | 5 |
| Breckenridge Acdf System | Highridge Medical, LLC | 5 |
Showing 12 of 50. All products under Stylet, Surgical, General & Plastic Surgery
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.