Integra®
Integra® Rosen Cartilage Knife, Double-Ended , 45 and 90 Degree Blades
2manufacturers in China registered for this device type
16catalogue 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 | KTG |
| Device type | Knife, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-17 |
| Record revised | 2025-07-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Do not use if package is damaged |
| Sizes | Width 3 to 5.5 mm; length 9.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1458233 | 5 | In distribution | |
| 3714168 | Width 4 mm | In distribution | |
| 3714244 | 10.5mm Blade | In distribution | |
| 3714163 | 6-1/4″ | In distribution | |
| 3714282 | 9.5mm Blade | In distribution | |
| 3714173 | In distribution | ||
| 1458234 | 5 | In distribution | |
| 3714167 | Width 3 mm | In distribution | |
| 3714172 | 6-1/2″ | In distribution | |
| 3714171 | In distribution | ||
| 3714246 | Width 5.5 mm | In distribution | |
| 3742000 | In distribution | ||
| 1458232 | 5 | In distribution | |
| 1458230 | 5 | In distribution | |
| 3714245 | 7-1/2″ | In distribution | |
| 1458231 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Boss Instruments | Boss Instruments, Ltd. | 91 |
| Ambler Surgical | Ambler Surgical, LLC | 87 |
| Aesculap | Aesculap AG | 48 |
| Pilling | Teleflex Medical LLC | 47 |
| Millennium | Avalign Technologies, Inc. | 41 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 38 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 31 |
| Avalign | Avalign Technologies, Inc. | 30 |
| HNM Medical | HNM Stainless, LLC. | 27 |
| V. Mueller | Steris Corporation | 25 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 25 |
| Rosen round knife | Spiggle & Theis Medizintechnik Gmbh | 22 |
Showing 12 of 83. All products under Knife, Ent
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.