Millennium
Hibbs Gouge, 9 1/2", curved, 3/8"
2manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | KAQ |
| Device type | Gouge, Nasal, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-22 |
| Record revised | 2023-07-06 (version 2) |
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 |
|---|---|---|
| 17-030010 | In distribution | |
| 1-380277 | In distribution | |
| 1-380275 | In distribution | |
| 17-030011 | In distribution | |
| 17-030009 | In distribution | |
| 1-250191 | In distribution | |
| 1-380276 | In distribution | |
| 1-030010 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novo Surgical | Novo Surgical, Inc. | 20 |
| Ambler Surgical | Ambler Surgical, LLC | 10 |
| Gouge | KLS-Martin L.P. | 8 |
| MicroFrance® | Integra Microfrance SAS | 5 |
| Sontec Micro Gouge | Sontec Instruments, Inc. | 4 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 3 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 1 |
| Alexander Mastoid Gouge | Sontec Instruments, Inc. | 1 |
| Jedmed | Jedmed Instrument Company | 1 |
| HNM Medical | HNM Stainless, LLC. | 1 |
| V. Mueller | Carefusion 2200, Inc. | 1 |
| Integra® | Integra LifeSciences Production Corporation | 1 |
Showing 12 of 13. All products under Gouge, Nasal, Ent
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.