Boss Instruments
Swan Neck Gouge, hex handle, 9" 1in Width Tapering to 9/16in
4manufacturers in China registered for this device type
53catalogue 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 | Boss Instruments, Ltd., 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-28 |
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 |
|---|---|---|
| 70-4201 | In distribution | |
| 70-4124 | In distribution | |
| 70-4227 | In distribution | |
| 70-4173 | In distribution | |
| 70-4270 | In distribution | |
| 70-4330 | In distribution | |
| 70-4140 | In distribution | |
| 70-4126 | In distribution | |
| 70-4125 | In distribution | |
| 70-4102 | In distribution | |
| 70-4103 | In distribution | |
| 70-4342 | In distribution | |
| 70-4346 | In distribution | |
| 70-4183 | In distribution | |
| 21-0140 | In distribution | |
| 70-4106 | In distribution | |
| 70-4136 | In distribution | |
| 70-4295 | In distribution | |
| 70-4202 | In distribution | |
| 70-4226 | In distribution | |
| 70-4392 | In distribution | |
| 70-4186 | In distribution | |
| 70-4258 | In distribution | |
| 70-4340 | In distribution | |
| 70-4204 | In distribution | |
| 70-4253 | In distribution | |
| 70-4176 | In distribution | |
| 70-4122 | In distribution | |
| 21-0101 | In distribution | |
| 70-4295L | In distribution | |
| 70-4181 | In distribution | |
| 70-4203 | In distribution | |
| 70-4383 | In distribution | |
| 21-0102 | In distribution | |
| 21-0103 | In distribution | |
| 70-4172 | In distribution | |
| 70-4120 | In distribution | |
| 77-0873 | In distribution | |
| 70-4225 | In distribution | |
| 70-4382 | In distribution | |
| 70-4344 | In distribution | |
| 70-4170 | In distribution | |
| 93-0240 | In distribution | |
| 70-4252 | In distribution | |
| 70-4384 | In distribution | |
| 70-4100 | In distribution | |
| 70-4381 | In distribution | |
| 70-4205 | In distribution | |
| 70-4380 | In distribution | |
| 70-4287L | In distribution | |
| 85-0148 | In distribution | |
| 70-4101 | In distribution | |
| 70-4138 | 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 |
| Orthomed | Ortho-MED, Inc. | 60 |
| 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.