Medicon
De Martel (Bailey) wire saw guide 33cm
4manufacturers in China registered for this device type
20catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shenzhen Airgle Corporation Limited | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Medicon eG. Chirurgiemechaniker-Genossenschaft |
|---|---|
| FDA product code | GDR |
| Device type | Saw, Manual And Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 77.04.70 | In distribution | ||
| 77.05.92 | In distribution | ||
| 57.64.92 | In distribution | ||
| 77.05.68 | In distribution | ||
| 77.05.62 | In distribution | ||
| 57.64.06 | 2 | In distribution | |
| 77.05.98 | In distribution | ||
| 77.03.65 | In distribution | ||
| 57.64.90 | In distribution | ||
| 77.05.74 | In distribution | ||
| 77.05.76 | In distribution | ||
| 57.64.02 | 2 | In distribution | |
| 77.05.35 | In distribution | ||
| 77.04.29 | In distribution | ||
| 77.05.40 | In distribution | ||
| 77.03.75 | In distribution | ||
| 57.64.60 | 5 | In distribution | |
| 57.64.40 | 5 | In distribution | |
| 77.02.23 | In distribution | ||
| 77.05.78 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 23 |
| Aesculap | Aesculap AG | 19 |
| gSource | Gsource, LLC. | 16 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 14 |
| ACE | Ace Surgical Supply Co., Inc. | 14 |
| Boss Instruments | Boss Instruments, Ltd. | 11 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 11 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 10 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 10 |
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 10 |
| Kmedic | Teleflex Medical LLC | 8 |
| Millennium | Avalign Technologies, Inc. | 7 |
Showing 12 of 46. All products under Saw, Manual And Accessories
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.