Integra® Miltex®
Integra® Miltex® Howard Bone File 7", No. 12A, Double-Ended, 5.3mm and 5.3mm wide, Plain and Cross Serrations
2manufacturers in China registered for this device type
12catalogue 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 | 2018-10-23 |
| Record revised | 2025-03-12 (version 9) |
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 |
| Sizes | Width 5 to 6.5 mm; length 7 in |
| Distribution end date | 2022-05-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40-1380 | 7-1/2″ | In distribution |
| PM-4410 | In distribution | |
| PM-4409 | Length 7 in | In distribution |
| 40-1371 | In distribution | |
| 40-1375 | In distribution | |
| PM-4411 | In distribution | |
| 40-1381 | In distribution | |
| 40-1385 | 7-1/4″ | In distribution |
| 40-1370 | In distribution | |
| 40-1382 | In distribution | |
| 40-2800 | In distribution | |
| 40-2802 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hayden Medical | Hayden Medical Inc | 11 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 10 |
| 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.