Aesculap
Smith-Ptrsn Osteotomes STR 205MM 13MM
4manufacturers in China registered for this device type
61catalogue 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 | Aesculap AG, Germany |
|---|---|
| FDA product code | GFI |
| Device type | Osteotome, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-05-06 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MB675R | In distribution | |
| FL556R | In distribution | |
| FL514R | In distribution | |
| FL788R | In distribution | |
| MB659R | In distribution | |
| MB665R | In distribution | |
| MB667R | In distribution | |
| MB689R | In distribution | |
| MB666R | In distribution | |
| MB681R | In distribution | |
| FL515R | In distribution | |
| FL527R | In distribution | |
| FL513R | In distribution | |
| FL523R | In distribution | |
| FL516R | In distribution | |
| MB685R | In distribution | |
| FL555R | In distribution | |
| FL557R | In distribution | |
| FL659R | In distribution | |
| MB679R | In distribution | |
| FL783R | In distribution | |
| MB676R | In distribution | |
| FL682R | In distribution | |
| FL662R | In distribution | |
| MB660R | In distribution | |
| FL790R | In distribution | |
| FL653R | In distribution | |
| FL785R | In distribution | |
| MB661R | In distribution | |
| MB678R | In distribution | |
| FL789R | In distribution | |
| FL651R | In distribution | |
| FL526R | In distribution | |
| FL524R | In distribution | |
| MB663R | In distribution | |
| MB680R | In distribution | |
| MB664R | In distribution | |
| FL660R | In distribution | |
| MB691R | In distribution | |
| MB669R | In distribution | |
| MB668R | In distribution | |
| FL652R | In distribution | |
| MB687R | In distribution | |
| FL517R | In distribution | |
| FL525R | In distribution | |
| FL650R | In distribution | |
| FL654R | In distribution | |
| FL554R | In distribution | |
| MB683R | In distribution | |
| MB662R | In distribution | |
| MB693R | In distribution | |
| MB688R | In distribution | |
| FL658R | In distribution | |
| MB690R | In distribution | |
| MB677R | In distribution | |
| MB684R | In distribution | |
| FL512R | In distribution | |
| FL656R | In distribution | |
| MB686R | In distribution | |
| MB694R | In distribution | |
| FL553R | In distribution |
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 |
| Power Dental USA | Power Dental U.S.A. Inc. | 66 |
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.