Osseoflex®
6 catalogue numbers from 00884450387405, listed by Merit Medical Systems, Inc., United States, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
6catalogue 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 | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | GAH |
| Device type | Stylet, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-05-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450387405 | Tip Type-Diamond and Bevel | In distribution |
| 00884450386842 | Gauge-10G | In distribution |
| 00884450327852 | Tip Type-Diamond and Bevel | In distribution |
| 00884450387436 | Gauge-10G | In distribution |
| 00884450327876 | Gauge-10G | In distribution |
| 00884450327883 | Gauge-10G | 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 |
| Inlet System Surgical Instrument | Jeil Medical Corporation | 5 |
| Disc Preparation Instruments | Highridge Medical, LLC | 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.