Tecomet
Zaufal-Jansen Rongeur 7" CVD 5 X 15MM
11manufacturers in China registered for this device type
44catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (5), Shandong (3), Jiangsu (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Qingdao Zhixing Medical Instrument Co., Ltd. | Qingdao | Shandong | Manufacturer | 6 |
Record
| Listed by | Tecomet, Inc., United States |
|---|---|
| FDA product code | HTX |
| Device type | Rongeur |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-21 |
| Record revised | 2023-10-03 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2327-14-000 | In distribution | |
| 55690 | In distribution | |
| 47490 | In distribution | |
| 2332-00-000 | In distribution | |
| 47997 | In distribution | |
| KMPR529 | In distribution | |
| 2420-41-000 | In distribution | |
| 2420-44-000 | In distribution | |
| 2317-00-000 | In distribution | |
| 7967029 | In distribution | |
| 47730 | In distribution | |
| 55961 | In distribution | |
| 2327-10-000 | In distribution | |
| 2311-12-000 | In distribution | |
| 47531 | In distribution | |
| 55693 | In distribution | |
| 2445-11-000 | In distribution | |
| 2313-00-000 | In distribution | |
| 47998 | In distribution | |
| 2420-40-000 | In distribution | |
| 55691 | In distribution | |
| 47480 | In distribution | |
| 47260 | In distribution | |
| 47999 | In distribution | |
| 47492 | In distribution | |
| 2340-00-000 | In distribution | |
| 2328-12-000 | In distribution | |
| 2333-32-000 | In distribution | |
| 47524 | In distribution | |
| 47840 | In distribution | |
| 47870 | In distribution | |
| 2314-10-000 | In distribution | |
| 2328-10-000 | In distribution | |
| 2598-07-690 | In distribution | |
| 2598-07-700 | In distribution | |
| 2310-12-000 | In distribution | |
| 47850 | In distribution | |
| 2311-10-000 | In distribution | |
| 55972 | In distribution | |
| 2305-10-000 | In distribution | |
| 2420-42-000 | In distribution | |
| 47258 | In distribution | |
| 2312-00-000 | In distribution | |
| 2333-26-000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 2,994 |
| Life Instruments | Life Instrument Corp. | 1,252 |
| Novo Surgical | Novo Surgical, Inc. | 1,227 |
| Surgical Direct | Surgical Direct, Inc. | 1,208 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 712 |
| gSource | Gsource, LLC. | 509 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 397 |
| Peak MED | Peak Medical Distribution Inc | 320 |
| Aesculap | Aesculap AG | 264 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 244 |
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 239 |
| HNM Medical | HNM Stainless, LLC. | 186 |
Showing 12 of 438. All products under Rongeur
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.