Instrapac
Instrapac Blacks Nail File Double Ended - Fine Arrow Head File X50
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 | Robinson Healthcare Limited, United Kingdom |
|---|---|
| FDA product code | GEO |
| Device type | File, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-06-23 |
| Record revised | 2026-02-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry and keep out of direct sunlight |
| Packaging | Box of 50, box of 200, box of 20 |
| Sizes | Length 18.5 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8436 | In distribution | |
| 8163 | In distribution | |
| 7859 | Length 18.5 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Miltex® | Integra LifeSciences Production Corporation | 12 |
| Hayden Medical | Hayden Medical Inc | 11 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 10 |
| 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.