Power Dental USA
OSTEOTOME 2.0mm (4-6-8-10-13-16-18-20-23-26mm) CONCAVE, LONG ANGLE OFFSET WITH KEY
4manufacturers in China registered for this device type
66catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Shanghai (1), Guangdong (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 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | Power Dental U.S.A. Inc. |
|---|---|
| FDA product code | GFI |
| Device type | Osteotome, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2021-07-13 |
| Record revised | 2023-04-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Distribution end date | 2023-03-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2099SR | In distribution | |
| 9009-BOSTC | In distribution | |
| 2097S | In distribution | |
| 9012-BOSTP | In distribution | |
| 2098 | In distribution | |
| 2050R | In distribution | |
| 2099R | In distribution | |
| 2100R | In distribution | |
| 2053S | In distribution | |
| 2051R | In distribution | |
| 2050 | In distribution | |
| 2051SR | In distribution | |
| 2045 | In distribution | |
| 2054S | In distribution | |
| 2095 | In distribution | |
| 2099S | In distribution | |
| 2055S | In distribution | |
| 9010-BOSTM | In distribution | |
| 2051S | In distribution | |
| 2054 | In distribution | |
| 2097R | In distribution | |
| 2056R | In distribution | |
| 2097SR | In distribution | |
| 2057 | In distribution | |
| 2097 | In distribution | |
| 2058 | In distribution | |
| 2050SC | In distribution | |
| 9011-BOSTN | In distribution | |
| 2098R | In distribution | |
| 2061 | In distribution | |
| 2096 | In distribution | |
| 2095SR | In distribution | |
| 2098SR | In distribution | |
| 2050SR | In distribution | |
| 2053 | In distribution | |
| 2055R | In distribution | |
| 2052 | In distribution | |
| 2051 | In distribution | |
| 2052R | In distribution | |
| 2096S | In distribution | |
| 2047 | In distribution | |
| 2048 | In distribution | |
| 2055SR | In distribution | |
| 2099 | In distribution | |
| 2096R | In distribution | |
| 2056SR | In distribution | |
| 2054SC | In distribution | |
| 2059 | In distribution | |
| 2052SR | In distribution | |
| 2095R | In distribution | |
| 9021-IMCH | In distribution | |
| 2060 | In distribution | |
| 9013-BOSTS | In distribution | |
| 2054R | In distribution | |
| 2051SC | In distribution | |
| 2095S | In distribution | |
| 2098S | In distribution | |
| 2055 | In distribution | |
| 2054SR | In distribution | |
| 2050S | In distribution | |
| 2053R | In distribution | |
| 2096SR | In distribution | |
| 2100 | In distribution | |
| 2053SR | In distribution | |
| 2046 | In distribution | |
| 2052S | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Steris Corporation | 155 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 131 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 121 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 110 |
| Osteotomy Instruments | Alphatec Spine, Inc. | 109 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 97 |
| Tecomet | Tecomet, Inc. | 76 |
| Timberline Lateral Fusion System | Highridge Medical, LLC | 75 |
| Orthomed | Ortho-MED, Inc. | 73 |
| Hayden Medical | Hayden Medical Inc | 70 |
| Ambler Surgical | Ambler Surgical, LLC | 67 |
| Osteotome, Manual | George Tiemann & Co. | 64 |
Showing 12 of 333. All products under Osteotome, Manual
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.