Ambler Surgical
Parkes hump gouge, 7'', straight, 6.0mm wide blade, double guarded cutting edge, flat handle
4manufacturers in China registered for this device type
164catalogue 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 | Ambler Surgical, LLC, 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 | 2021-01-04 |
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 |
|---|---|---|
| Hibbs gouge | In distribution | |
| Bishop mastoid gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Cobb gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Stille-type gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Bone gouge | In distribution | |
| Bone gouge | In distribution | |
| Bone gouge | In distribution | |
| Partsch gouge | In distribution | |
| Stille-type gouge | In distribution | |
| Partsch gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Cobb gouge | In distribution | |
| Stille-type gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Cobb gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Stille-type gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Partsch gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Alexander mastoid gouge | In distribution | |
| Stille-type gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Sheehan gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Stille-type gouge | In distribution | |
| Lexer-Mini gouge | In distribution | |
| Stille-type gouge | In distribution | |
| Shoulder penetrating gouge | In distribution | |
| Carpener gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Cobb spinal gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Bone gouge | In distribution | |
| Stille-type gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Cobb gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Partsch gouge | In distribution | |
| Partsch gouge | In distribution | |
| U.S. Army pattern gouge | In distribution | |
| Partsch gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Cobb spinal gouge | In distribution | |
| Cobb spinal gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Cobb gouge | In distribution | |
| Parkes hump gouge | In distribution | |
| Partsch gouge | In distribution | |
| Lexer-Mini gouge | In distribution | |
| Carpener gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Sheehan gouge | In distribution | |
| Bishop mastoid gouge | In distribution | |
| Hibbs gouge | In distribution | |
| U.S. Army pattern gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Alexander mastoid gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Cobb spinal gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Freer gouge | In distribution | |
| Sheehan gouge | In distribution | |
| Zielke gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Partsch gouge | In distribution | |
| Stille-type gouge | In distribution | |
| Partsch gouge | In distribution | |
| Alexander mastoid gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Bone gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Partsch gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Bone gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Bishop mastoid gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Bone gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Partsch gouge | In distribution | |
| Bone gouge | In distribution | |
| Cobb gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Stille-type gouge | In distribution | |
| Bone gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Alexander mastoid gouge | In distribution | |
| Gouge | In distribution | |
| Stille-type gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Bishop mastoid gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Sheehan gouge | In distribution | |
| Bone gouge | In distribution | |
| Bone gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Cobb gouge | In distribution | |
| Carpener gouge | In distribution | |
| Partsch gouge | In distribution | |
| Alexander mastoid gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Partsch gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Bone gouge | In distribution | |
| Partsch gouge | In distribution | |
| Carpener gouge | In distribution | |
| Bishop mastoid gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| U.S. Army pattern gouge | In distribution | |
| Alexander mastoid gouge | In distribution | |
| Hibbs gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Cobb gouge | In distribution | |
| Stille-type gouge | In distribution | |
| Bone gouge | In distribution | |
| Stille-type gouge | In distribution | |
| Smith-Peterson gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Dahmen-Lexer gouge | In distribution | |
| Bone gouge | In distribution | |
| Stille-type gouge | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 206 |
| 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 |
| 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.