Sontec Micro Gouge
4 catalogue numbers from 475-804, listed by Sontec Instruments, Inc., United States, under Gouge, Nasal, Ent. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
4catalogue 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 | Sontec Instruments, Inc., United States |
|---|---|
| FDA product code | KAQ |
| Device type | Gouge, Nasal, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2018-09-11 |
| Record revised | 2019-05-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Dry Heat Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 5.5 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 475-804 | Length 5.5 in | In distribution |
| 475-806 | Length 5.5 in | In distribution |
| 475-803 | Length 5.5 in | In distribution |
| 475-805 | Length 5.5 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novo Surgical | Novo Surgical, Inc. | 20 |
| Ambler Surgical | Ambler Surgical, LLC | 10 |
| Millennium | Avalign Technologies, Inc. | 8 |
| Gouge | KLS-Martin L.P. | 8 |
| MicroFrance® | Integra Microfrance SAS | 5 |
| 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.