12mm Distraction Pin-Double
12mm Distraction Pin-Double Quantity 10 DI 00850014548070
10manufacturers in China registered for this device type
2catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Shandong (2), Tianjin (2), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Premier Guard Zhongshan Limited | Zhongshan | Guangdong | Contract manufacturer | 10 |
| Tonglu Qianyan Medtech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tianjin Water Source Tech Co., Ltd. | Tianjin | Tianjin | Manufacturer | 27 |
| Plasdent Shanghai Co., Ltd. | Shanghai | Shanghai | Manufacturer | 24 |
| Tianjin Medicines & Health Products IMP. & EXP. Corp. | Tianjin | Tianjin | Exporter | 16 |
| Orihealth Medical Products(Suzhou)Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Folsom Metal Products, Inc., United States |
|---|---|
| FDA product code | GCZ |
| Device type | Retainer, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-03-18 |
| Record revised | 2023-06-02 (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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 301.912S2 | In distribution | |
| 301.91S2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Omnia Medical TiBrid™- A/SA | Omnia Medical | 7 |
| Viscera Retainer, Fish | Adept-MED Intl., Inc. | 6 |
| Viscera Retainer Radiopaque Center Spine | Rainbow Medical Devices LLC | 4 |
| Matira Anterior Cervical System | Kalitec Direct, LLC | 3 |
| 14mm Distraction Pin-Double | Folsom Metal Products, Inc. | 2 |
| Surgeon Sturgeon | Flexbar Machine Corp. | 2 |
| 12mm Distraction Pin | Folsom Metal Products, Inc. | 2 |
| 14mm Distraction Pin | Folsom Metal Products, Inc. | 2 |
| Post Drill Guide Sleeve, 45mm | Toby Orthopaedics | 1 |
| LapPakOR | THE O R Company PTY Ltd | 1 |
| SurgiFish | Greer Medical, Inc. | 1 |
| Breast Implant Protector | Adept-MED Intl., Inc. | 1 |
Showing 12 of 15. All products under Retainer, Surgical
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Folsom Metal Products, Inc. | UDI-DI | 2025-08-21 | Class II | Incorrect or no expiration date | Labeling includes shelf life that has not been validated. | 160 units |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-08-21 | Class II | Incorrect or no expiration date | Labeling includes shelf life that has not been validated. | 10,960 units |
| 2025-08-21 | Class II | Incorrect or no expiration date | Labeling includes shelf life that has not been validated. | 2,700 units |
| 2025-08-21 | Class II | Incorrect or no expiration date | Labeling includes shelf life that has not been validated. | 490 units |
| 2025-08-21 | Class II | Incorrect or no expiration date | Labeling includes shelf life that has not been validated. | |
| 2025-08-21 | Class II | Incorrect or no expiration date | Labeling includes shelf life that has not been validated. | 3790 unit |
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.