Aesculap
Tuning Fork W/Clmp: C64 W/O Clmp: C128
11manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (5), Shanghai (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Goldsun Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
| Wenzhou Kangju Medical Instrument Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 15 |
| ADC Ningbo Co., Ltd. | Ningbo | Zhejiang | Exporter | 13 |
| MDF Instruments Medifriend Inc. | Song Jiang District | Shanghai | Repacker / relabeller | 13 |
| Ningbo Yongjin Medical Instruments Manufacture Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 8 |
| Ningbo Haishu Haoxin Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 6 |
| Taihu Huamei Medical Equipment Co., Ltd. | Anqing | Anhui | Contract manufacturer | 5 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | GWX |
| Device type | Fork, Tuning |
| Device class | Class 1 |
| Regulation | 21 CFR 882.1525 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-17 |
| Record revised | 2021-05-07 (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 |
| Distribution end date | 2022-07-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MB575A | In distribution | |
| OF017N | In distribution | |
| OF015N | Withdrawn | |
| OF003N | Withdrawn | |
| OF016N | Withdrawn | |
| OF018N | Withdrawn | |
| OF002N | Withdrawn | |
| OF031N | Withdrawn | |
| OF004N | Withdrawn | |
| OF019N | Withdrawn | |
| OF006N | Withdrawn | |
| OF001N | Withdrawn | |
| OF010N | Withdrawn | |
| OF033N | Withdrawn | |
| OF005N | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fentex | Fentex medical GmbH | 22 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 20 |
| ADC® | American Diagnostic Corp. | 13 |
| HNM Medical | HNM Stainless, LLC. | 12 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 11 |
| BR Surgical, LLC | BR Surgical LLC | 11 |
| Bear | Bear-ENT, LLC | 10 |
| Ambler Surgical | Ambler Surgical, LLC | 7 |
| Sontec Tuning Fork | Sontec Instruments, Inc. | 7 |
| mytaMed | Mytamed, Inc. | 6 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 5 |
| Integra® | Integra LifeSciences Production Corporation | 5 |
Showing 12 of 34. All products under Fork, Tuning
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.