Boss Instruments
Billeau Ear Loop, med 3mm loop
2manufacturers in China registered for this device type
3catalogue 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 | Boss Instruments, Ltd., United States |
|---|---|
| FDA product code | JYQ |
| Device type | Loop, Wire |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-28 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90-1122 | In distribution | |
| 90-1120 | In distribution | |
| 90-1124 | 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.