Integra® Miltex®
Integra® Miltex® Ferguson Gall Stone Scoop, 9-1/2", Double-Ended, Large Size Scoops
2manufacturers in China registered for this device type
6catalogue 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 | FHL |
| Device type | Scoop |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-06-28 |
| Record revised | 2024-03-06 (version 8) |
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 |
|---|---|---|
| 14-26-S | 9-1/2″ | In distribution |
| PM-1476A | In distribution | |
| PM-1476B | In distribution | |
| 14-26-L | 9-1/2″ | In distribution |
| 14-22 | In distribution | |
| 14-26-M | 9-1/2″ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar | Sklar Corporation | 21 |
| Aesculap | Aesculap AG | 18 |
| V. Mueller | Steris Corporation | 13 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 12 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 11 |
| Ambler Surgical | Ambler Surgical, LLC | 11 |
| Novo Surgical | Novo Surgical, Inc. | 8 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 7 |
| Gimmi | Gimmi Gmbh | 6 |
| Symmetry Desjardins | Aspen Surgical Products, Inc. | 4 |
| Anmuth Medical International | Anmuth Medical International LLC | 4 |
| Davis Gall Stone Scoop | Sontec Instruments, Inc. | 3 |
Showing 12 of 21. All products under Scoop
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.