Orthomed
Gouge Blade 70MM RAD. FOR OM49-630
4manufacturers in China registered for this device type
60catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Jiangsu (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 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Ortho-MED, Inc., United States |
|---|---|
| FDA product code | GDH |
| Device type | Gouge, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-09-14 |
| Record revised | 2024-07-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OM 49-0648 | In distribution | |
| OM 55-0630 | In distribution | |
| OM 46-0477 | In distribution | |
| OM 46-0490 | In distribution | |
| OM 46-0401 | In distribution | |
| OM 46-0403 | In distribution | |
| OM 46-0395 | In distribution | |
| OM 49-0036 | In distribution | |
| OM 49-0053 | In distribution | |
| OM 46-0487 | In distribution | |
| OM 49-0084 | In distribution | |
| OM 49-0024 | In distribution | |
| OM 46-0292 | In distribution | |
| OM 49-0054 | In distribution | |
| OM 46-0489 | In distribution | |
| OM 49-0274 | In distribution | |
| OM 46-0387 | In distribution | |
| OM 46-0468 | In distribution | |
| OM 49-0020 | In distribution | |
| OM 46-0412 | In distribution | |
| OM 46-0388 | In distribution | |
| OM 46-0467 | In distribution | |
| OM 46-0411 | In distribution | |
| OM 49-0055 | In distribution | |
| OM 46-0410 | In distribution | |
| OM 46-0478 | In distribution | |
| OM 46-0476 | In distribution | |
| OM 46-0390 | In distribution | |
| OM 46-0393 | In distribution | |
| OM 49-0050 | In distribution | |
| OM 46-0405 | In distribution | |
| OM 49-0032 | In distribution | |
| OM 46-0394 | In distribution | |
| OM 46-0488 | In distribution | |
| OM 46-0389 | In distribution | |
| OM 46-0466 | In distribution | |
| OM 49-0277 | In distribution | |
| OM 46-0407 | In distribution | |
| OM 46-0402 | In distribution | |
| OM 46-0491 | In distribution | |
| OM 46-0391 | In distribution | |
| OM 49-0052 | In distribution | |
| OM 46-0495 | In distribution | |
| OM 46-0404 | In distribution | |
| OM 49-0018 | In distribution | |
| OM 49-0644 | In distribution | |
| OM 49-0030 | In distribution | |
| OM 49-0640 | In distribution | |
| OM 46-0293 | In distribution | |
| OM 46-0392 | In distribution | |
| OM 46-0294 | In distribution | |
| OM 46-0479 | In distribution | |
| OM 46-0493 | In distribution | |
| OM 46-0919 | In distribution | |
| OM 46-0408 | In distribution | |
| OM 49-0051 | In distribution | |
| OM 49-0272 | In distribution | |
| OM 49-0022 | In distribution | |
| OM 46-0409 | In distribution | |
| OM 49-0034 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 206 |
| Ambler Surgical | Ambler Surgical, LLC | 164 |
| Life Instruments | Life Instrument Corp. | 131 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 103 |
| Surtex | Surtex Instruments Ltd | 95 |
| Novo Surgical | Novo Surgical, Inc. | 89 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 86 |
| Aesculap | Aesculap AG | 82 |
| gSource | Gsource, LLC. | 71 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 64 |
| Boss Instruments | Boss Instruments, Ltd. | 53 |
| Gouge | KLS-Martin L.P. | 40 |
Showing 12 of 77. All products under Gouge, Surgical, General & Plastic Surgery
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.