Novo Surgical Inc.
lexer gouge, w/ sterilizable (up to 143 degrees c) plastic handle, 5.0 mm, 8-5/8" (22.0 cm)
4manufacturers in China registered for this device type
18catalogue 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 | Novo Surgical, 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 | 2022-11-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N3973-66 | In distribution | |
| N3939-15 | In distribution | |
| D5451-88 | In distribution | |
| N3939-21 | In distribution | |
| N3963-17 | In distribution | |
| N3963-86 | In distribution | |
| N3964-22 | In distribution | |
| N3983-17 | In distribution | |
| N3983-23 | In distribution | |
| N3956-31 | In distribution | |
| N3983-31 | In distribution | |
| N3991-32 | In distribution | |
| N3972-12 | In distribution | |
| N3983-26 | In distribution | |
| N3983-67 | In distribution | |
| N3983-73 | In distribution | |
| N3963-81 | In distribution | |
| N93963-73 | 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.