Integra®
Integra® Shea Speculum Holder
2manufacturers in China registered for this device type
1catalogue number
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 | Integra LifeSciences Production Corporation, 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, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-24 |
| Record revised | 2023-04-18 (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 |
|---|---|---|
| 3724316 | 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 |
| Gyrus Acmi, Inc | Gyrus Acmi, Inc. | 2 |
| Intrace USA | Pilotis Tech LLC | 1 |
| Tumarkin Ear Specula size 0.5 (4.5mm) | DTR Medical Ltd | 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.