Marina Medical
Rubin Nasal-Lateral Osteotome (U-Shape with sharp knife to narrow Dorsum width)
4manufacturers in China registered for this device type
62catalogue 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 | Marina Medical Instruments, Inc., United States |
|---|---|
| FDA product code | GFI |
| Device type | Osteotome, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-07 |
| Record revised | 2024-02-21 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Sizes | Length 16 to 20 cm; width 3 to 6 mm; outer diameter 4 to 6 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 200-124 | Length 16 cm | In distribution |
| 200-152 | Length,18,cm | In distribution |
| 200-126 | Length 16 cm | In distribution |
| 200-114 | Length 18.5 cm | In distribution |
| 289-251 | In distribution | |
| 200-601 | In distribution | |
| 289-266 | In distribution | |
| 289-248 | In distribution | |
| 200-154 | Length 18 cm | In distribution |
| 200-122 | Length 16 cm | In distribution |
| 200-112 | Length 18.5 cm | In distribution |
| 200-167 | Length 18 cm | In distribution |
| 200-164 | Length 18 cm | In distribution |
| 200-144 | Width 3 mm | In distribution |
| 200-602 | In distribution | |
| 200-145 | Width,2,mm | In distribution |
| 200-110 | Length 18.5 cm | In distribution |
| 200-168 | Length 18 cm | In distribution |
| 200-132 | Length 16 cm | In distribution |
| 200-128 | Length 16 cm | In distribution |
| 200-138 | Width,4,mm | In distribution |
| 200-150 | Length,18,cm | In distribution |
| 200-184 | Length,20,cm | In distribution |
| 200-141 | Width 3 mm | In distribution |
| 200-110EC | Length 18.5 cm | In distribution |
| 200-148 | Length,18,cm | In distribution |
| 200-137 | Width,3,mm | In distribution |
| 200-127 | Length 16 cm | In distribution |
| 200-600 | In distribution | |
| 200-156 | Length 18 cm | In distribution |
| 200-136 | Width,2,mm | In distribution |
| 200-169 | Length 18 cm | In distribution |
| 200-162 | Length 18 cm | In distribution |
| 200-176 | Length 18 cm | In distribution |
| 200-166 | Length 18 cm | In distribution |
| 289-250 | In distribution | |
| 200-130 | Length 16 cm | In distribution |
| 289-246 | In distribution | |
| 200-170 | Length 18 cm | In distribution |
| 200-175 | Length 18 cm | In distribution |
| 200-158 | Length,18,cm | In distribution |
| 200-179 | Length 18 cm | In distribution |
| 289-252 | In distribution | |
| 289-247 | In distribution | |
| 200-143 | In distribution | |
| 289-264 | In distribution | |
| 200-174 | Length 18 cm | In distribution |
| 200-183 | Length 20 cm | In distribution |
| 200-182 | Length 20 cm | In distribution |
| 200-194 | Length 18 cm | In distribution |
| 200-178 | Length 18 cm | In distribution |
| 200-140 | Length 18 cm | In distribution |
| 200-116 | Length 18.5 cm | In distribution |
| 200-139 | Width 6 mm | In distribution |
| 200-112EC | Length 18.5 cm | In distribution |
| 200-142 | Width 4 mm | In distribution |
| 200-177 | Length 18 cm | In distribution |
| 200-123 | Length,16,cm | In distribution |
| 200-135 | Length 16 cm | In distribution |
| 200-160 | Length,18,cm | In distribution |
| 200-281 | Outer Diameter 6 mm | In distribution |
| 200-280 | Outer Diameter 4 mm | 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.