Pediguard Threaded
2 catalogue numbers from STARTER Pin 1, listed by Spineguard, SA, France, under Stylet, Surgical, General & Plastic Surgery. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue 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 | Spineguard, SA, France |
|---|---|
| FDA product code | GAH |
| Device type | Stylet, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-12-26 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -5 to 30 °C; Handling environment temperature -10 to 50 °C; Storage environment humidity up to 90 % RH; Handling environment humidity up to 90 % RH |
| Sizes | Length 308 to 389.5 mm; outer diameter 1.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STARTER Pin 1 | Length 308 mm | In distribution |
| STARTER Pin 5 | Outer Diameter 1.6 mm | 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 |
| 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 |
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.