Avalign
Hibbs Gouge Curved, 5/8" Wide OL245mm(9 5/8")
4manufacturers in China registered for this device type
24catalogue 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 | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | GDH |
| Device type | Gouge, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-11-03 |
| Record revised | 2023-07-06 (version 3) |
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 |
|---|---|---|
| VM81-5282 | In distribution | |
| VM104-1351 | In distribution | |
| VM81-5338 | In distribution | |
| VM32-1237 | In distribution | |
| VM81-5336 | In distribution | |
| VM81-5234 | In distribution | |
| VM81-5453 | In distribution | |
| VM81-5451 | In distribution | |
| VM81-5314 | In distribution | |
| VM81-5231 | In distribution | |
| VM81-5212 | In distribution | |
| VM81-5316 | In distribution | |
| VM81-5455 | In distribution | |
| VM81-5330 | In distribution | |
| VM81-5233 | In distribution | |
| VM81-5211 | In distribution | |
| VM81-5339 | In distribution | |
| VM81-5235 | In distribution | |
| VM81-5411 | In distribution | |
| VM81-5311 | In distribution | |
| VM32-1235 | In distribution | |
| VM32-1251 | In distribution | |
| VM81-5457 | In distribution | |
| VM81-4963 | 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 |
| Boss Instruments | Boss Instruments, Ltd. | 53 |
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.