Integra® Miltex®
Integra® Miltex® Alexander Mastoid Chisel, 7", 10mm wide
1manufacturer
6catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | JYD |
| Device type | Chisel, Mastoid |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-12-21 |
| Record revised | 2023-04-27 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19-754 | In distribution | |
| 19-756 | In distribution | |
| 19-752 | In distribution | |
| 19-760 | In distribution | |
| 19-750 | In distribution | |
| 19-758 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 12 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 10 |
| PediatrOS™ FlexTack™/ RigidTack™ | Merete Gmbh | 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.