Integra®
Integra® House-Billeau Ear Loop, 6-1/2", 3.5mm Oval
2manufacturers in China registered for this device type
4catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | JYQ |
| Device type | Loop, Wire |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-24 |
| Record revised | 2023-04-17 (version 4) |
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 |
|---|---|---|
| 3724055 | In distribution | |
| 3724058 | In distribution | |
| 3724057 | In distribution | |
| 3724056 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Marina Medical | Marina Medical Instruments, Inc. | 42 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 21 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 11 |
| MicroFrance® | Integra Microfrance SAS | 10 |
| BR Surgical, LLC | BR Surgical LLC | 9 |
| V. Mueller | Steris Corporation | 8 |
| gSource | Gsource, LLC. | 6 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 6 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 6 |
| Millennium | Avalign Technologies, Inc. | 5 |
| Moria | Moria, Inc. | 5 |
| Bear | Bear-ENT, LLC | 4 |
Showing 12 of 39. All products under Loop, Wire
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.