Tecomet
Mallet Light Chrome HANDLE-1 LB 2 OZ/8 OZ
6manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (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 |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Tecomet, Inc., United States |
|---|---|
| FDA product code | HXL |
| Device type | Mallet |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-10-12 |
| Record revised | 2023-11-16 (version 2) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KMPR3073 | In distribution | |
| 49760 | In distribution | |
| AR-2966 | In distribution | |
| 46689 | In distribution | |
| 49766 | In distribution | |
| 49765 | In distribution | |
| 46658 | In distribution | |
| 46663 | In distribution | |
| 46662 | In distribution | |
| 46667 | In distribution | |
| PR53363 | In distribution | |
| KMPR5033 | In distribution | |
| AR-8826M | In distribution | |
| KMPR3637 | In distribution | |
| 46687 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MSI Precision Specialty Instruments | MED Saver, Inc. | 115 |
| Surgical Direct | Surgical Direct, Inc. | 77 |
| Aesculap | Aesculap AG | 24 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 20 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 18 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 17 |
| Princeton | Princeton Medical Group, Inc. | 14 |
| Hayden Medical | Hayden Medical Inc | 12 |
| General Instruments | Alphatec Spine, Inc. | 11 |
| Sontec Mallet | Sontec Instruments, Inc. | 9 |
| Mallet | Zimmer, Inc. | 8 |
| Marina Medical | Marina Medical Instruments, Inc. | 8 |
Showing 12 of 132. All products under Mallet
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.