Jedmed
Gouge Parkes Double Guard
2manufacturers in China registered for this device type
1catalogue number
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 | Jedmed Instrument Company, United States |
|---|---|
| FDA product code | KAQ |
| Device type | Gouge, Nasal, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 51-4391 | 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 |
| 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 |
| 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.