Ambler Surgical
Killian-Claus septum gouge, 6 3/4'', bayonet shaft, straight, 6.0mm wide blade, with notch, square handle
2manufacturers in China registered for this device type
10catalogue 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 | Ambler Surgical, LLC, 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 | 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 |
|---|---|---|
| Read nasal gouge | In distribution | |
| Read nasal gouge | In distribution | |
| Read nasal gouge | In distribution | |
| Tendon gouge | In distribution | |
| Killian-Claus septum gouge | In distribution | |
| Tendon gouge | In distribution | |
| Tendon gouge | In distribution | |
| Killian septum gouge | In distribution | |
| Read nasal gouge | In distribution | |
| Killian septum gouge | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novo Surgical | Novo Surgical, Inc. | 20 |
| Millennium | Avalign Technologies, Inc. | 8 |
| 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.