Novo Surgical
lexer gouge, w/ sterilizable (up to 143 degrees c) plastic handle, 10.0 mm, 8 5/8" (22.0 cm)
4manufacturers in China registered for this device type
89catalogue 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 | 2023-12-18 |
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 |
|---|---|---|
| N3963-33 | In distribution | |
| N3963-27 | In distribution | |
| N93983-10 | In distribution | |
| N3963-73 | In distribution | |
| N93963-81 | In distribution | |
| N93939-17 | In distribution | |
| N3963-83 | In distribution | |
| N3983-76 | In distribution | |
| N93963-67 | In distribution | |
| N93972-12 | In distribution | |
| N3956-36 | In distribution | |
| N93983-73 | In distribution | |
| N3973-64 | In distribution | |
| N3956-21 | In distribution | |
| N3933-23 | In distribution | |
| N93983-26 | In distribution | |
| N93963-21 | In distribution | |
| N3983-81 | In distribution | |
| N93983-23 | In distribution | |
| N3963-01 | In distribution | |
| N93983-31 | In distribution | |
| N3963-71 | In distribution | |
| N3933-29 | In distribution | |
| N3991-22 | In distribution | |
| D95451-88 | In distribution | |
| N93973-62 | In distribution | |
| N3991-35 | In distribution | |
| N93956-36 | In distribution | |
| N3983-60 | In distribution | |
| N93963-27 | In distribution | |
| N3939-17 | In distribution | |
| N3983-36 | In distribution | |
| N3983-41 | In distribution | |
| N3963-23 | In distribution | |
| D5451-80 | In distribution | |
| N3963-41 | In distribution | |
| N93983-60 | In distribution | |
| N3939-23 | In distribution | |
| N3963-51 | In distribution | |
| N93983-81 | In distribution | |
| N3964-15 | In distribution | |
| N93933-23 | In distribution | |
| N93983-17 | In distribution | |
| N3991-25 | In distribution | |
| N3964-24 | In distribution | |
| N3963-36 | In distribution | |
| N93939-23 | In distribution | |
| N93963-71 | In distribution | |
| N93933-17 | In distribution | |
| N93963-41 | In distribution | |
| N3991-24 | In distribution | |
| N3963-77 | In distribution | |
| N93963-31 | In distribution | |
| N3972-13 | In distribution | |
| N3964-26 | In distribution | |
| N93983-76 | In distribution | |
| N93963-86 | In distribution | |
| N93963-77 | In distribution | |
| N3963-43 | In distribution | |
| N3983-86 | In distribution | |
| N93963-23 | In distribution | |
| N3964-14 | In distribution | |
| N3991-33 | In distribution | |
| N3983-91 | In distribution | |
| N3956-23 | In distribution | |
| N93963-33 | In distribution | |
| N3964-13 | In distribution | |
| N3956-19 | In distribution | |
| N93963-17 | In distribution | |
| N3991-23 | In distribution | |
| N3963-93 | In distribution | |
| N3964-16 | In distribution | |
| N3973-62 | In distribution | |
| N3939-19 | In distribution | |
| N3956-26 | In distribution | |
| N3963-21 | In distribution | |
| N3963-91 | In distribution | |
| N3933-17 | In distribution | |
| N93983-67 | In distribution | |
| N3991-34 | In distribution | |
| N3964-23 | In distribution | |
| N3963-31 | In distribution | |
| N93963-83 | In distribution | |
| N3964-25 | In distribution | |
| N3963-67 | In distribution | |
| N3939-25 | In distribution | |
| N3983-10 | In distribution | |
| N93956-31 | In distribution | |
| N3964-12 | 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 |
| 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.