Integra®
Integra® Saunders Paparella Window Rasp & Marker, Malleable Shaft Marked at 4, 4.5, & 5 mm
2manufacturers in China registered for this device type
5catalogue 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 | JYY |
| Device type | Rasp, Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-24 |
| Record revised | 2023-08-08 (version 5) |
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, manufacturing date |
| Sizes | Outer diameter 0.4 to 0.7 mm; angle 15 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3722086 | 6-1/2″ | In distribution |
| 3722093 | Outer Diameter 0.7 mm | In distribution |
| 3722107 | In distribution | |
| 3722092 | Angle 15 ° | In distribution |
| 3722087 | 6-1/2″ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 11 |
| MicroFrance® | Integra Microfrance SAS | 7 |
| Pilling | Teleflex Medical LLC | 7 |
| Sontec EAR Raspatory | Sontec Instruments, Inc. | 5 |
| Millennium | Avalign Technologies, Inc. | 4 |
| Aesculap | Aesculap AG | 4 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 4 |
| Hayden Medical | Hayden Medical Inc | 4 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 4 |
| V. Mueller | Steris Corporation | 3 |
| Avalign | Avalign Technologies, Inc. | 3 |
| Kistler EAR Cartilage Raspatory | Sontec Instruments, Inc. | 2 |
Showing 12 of 21. All products under Rasp, Ear
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.