Gyrus Acmi, Inc
Speculum Holder With Schuknecht Modification
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | JYK |
| Device type | Holder, Ear Speculum |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-07 |
| Record revised | 2024-09-02 (version 3) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 130072 | In distribution | |
| 130074 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MicroFrance® | Integra Microfrance SAS | 5 |
| Bear | Bear-ENT, LLC | 4 |
| Mentio disposable ear specula | Spiggle & Theis Medizintechnik Gmbh | 4 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 2 |
| Bear | Mytamed, Inc. | 2 |
| Intrace USA | Pilotis Tech LLC | 1 |
| Tumarkin Ear Specula size 0.5 (4.5mm) | DTR Medical Ltd | 1 |
| Integra® | Integra LifeSciences Production Corporation | 1 |
| Mentio disposable ear curette/cotton | Spiggle & Theis Medizintechnik Gmbh | 1 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 1 |
| Pilling | Teleflex Medical LLC | 1 |
| Instrumentation Difra SA | Instrumentation Difra SA | 1 |
Showing 12 of 15. All products under Holder, Ear Speculum
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.