Integra® Jarit®
Integra® Jarit® Miller Bone File 7-1/2", No. 45, Double-Ended, 7.2mm and 5.6mm Wide, Plain Serrations
2manufacturers in China registered for this device type
10catalogue 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 | GEO |
| Device type | File, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-05-02 |
| Record revised | 2024-05-27 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Width 5 to 6.3 mm; length 7 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X512482 | In distribution | |
| 835305 | In distribution | |
| P4409 | Width 5 mm | In distribution |
| P4411 | In distribution | |
| X512491 | In distribution | |
| 835310 | 7-1/4″ | In distribution |
| 842100 | In distribution | |
| X512481 | In distribution | |
| P4410 | In distribution | |
| X512486 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Miltex® | Integra LifeSciences Production Corporation | 12 |
| Hayden Medical | Hayden Medical Inc | 11 |
| Instrapac | Robinson Healthcare Limited | 3 |
| File | KLS-Martin L.P. | 2 |
| DJO Surgical | DJO, LLC | 2 |
| Carnegie Surgical LLC | Carnegie Surgical LLC | 1 |
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.