Hayden Medical
Smith-Petersen Osteotome 8" (20cm), straight 1/2" (1.3cm) wide, round handle
4manufacturers in China registered for this device type
70catalogue 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 | Hayden Medical Inc, United States |
|---|---|
| FDA product code | GFI |
| Device type | Osteotome, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-03-14 |
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 |
|---|---|---|
| 270-506 | In distribution | |
| 270-499 | In distribution | |
| 270-504 | In distribution | |
| 270-334 | In distribution | |
| 270-483 | In distribution | |
| 270-500 | In distribution | |
| 270-331 | In distribution | |
| 270-303 | In distribution | |
| 270-343 | In distribution | |
| 270-442 | In distribution | |
| 270-494 | In distribution | |
| 270-606 | In distribution | |
| 270-493 | In distribution | |
| 270-448 | In distribution | |
| 270-449 | In distribution | |
| 270-607 | In distribution | |
| 270-444 | In distribution | |
| 270-442C | In distribution | |
| 270-442C-7 | In distribution | |
| 270-440 | In distribution | |
| 270-446C-7 | In distribution | |
| 270-440C | In distribution | |
| 270-490 | In distribution | |
| 270-605 | In distribution | |
| 270-438C | In distribution | |
| 270-603 | In distribution | |
| 270-444C | In distribution | |
| 270-501 | In distribution | |
| 270-448C | In distribution | |
| 270-485 | In distribution | |
| 270-447 | In distribution | |
| 270-502 | In distribution | |
| 270-337 | In distribution | |
| 270-497 | In distribution | |
| 270-509 | In distribution | |
| 270-599 | In distribution | |
| 270-498 | In distribution | |
| 270-604 | In distribution | |
| 270-338 | In distribution | |
| 270-447C | In distribution | |
| 270-508 | In distribution | |
| 270-484 | In distribution | |
| 270-449C | In distribution | |
| 270-505 | In distribution | |
| 270-452C | In distribution | |
| 270-332 | In distribution | |
| 270-487 | In distribution | |
| 270-336 | In distribution | |
| 270-450C | In distribution | |
| 270-446C | In distribution | |
| 270-333 | In distribution | |
| 270-482 | In distribution | |
| 270-450 | In distribution | |
| 270-507 | In distribution | |
| 270-503 | In distribution | |
| 270-438C-7 | In distribution | |
| 270-489 | In distribution | |
| 270-488 | In distribution | |
| 270-486 | In distribution | |
| 270-446 | In distribution | |
| 270-601 | In distribution | |
| 270-491 | In distribution | |
| 270-602 | In distribution | |
| 270-335 | In distribution | |
| 270-492 | In distribution | |
| 270-452 | In distribution | |
| 810-308 | In distribution | |
| 270-600 | In distribution | |
| 270-438 | In distribution | |
| 270-514 | 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 |
| Ambler Surgical | Ambler Surgical, LLC | 67 |
| Power Dental USA | Power Dental U.S.A. Inc. | 66 |
| 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.