Integra®
Integra® McCabe Flap Knife Dissector, Double Ended, Blades 2mm*3mm, 25 degree & 45 degree, 7-1/4"
2manufacturers in China registered for this device type
32catalogue 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 | JYO |
| Device type | Knife, 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 | 2024-10-11 (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 | Width 0.5 to 4 mm; length 6 in; length 2 to 170 mm; angle 20 to 60 °; outer diameter 0.75 to 3 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3722028 | Length 6 in | In distribution |
| 3722152 | Length 6 in | In distribution |
| 3722110 | In distribution | |
| 3722123 | In distribution | |
| 3722029 | Width 3 mm | In distribution |
| 3722041 | Angle 60 ° | In distribution |
| 3722122 | In distribution | |
| 3722084 | Length 6 in | In distribution |
| 3722134 | Length 7 mm | In distribution |
| 3722043 | Length 6 mm | In distribution |
| 3722042 | Width 0.5 mm | In distribution |
| 3722037 | Length 6 in | In distribution |
| 3722026 | Width 4 mm | In distribution |
| 3724279 | 7-1/2″ | In distribution |
| 3722083 | 6-1/2″ | In distribution |
| 3722158 | In distribution | |
| 3722085 | In distribution | |
| 3722022 | 6-1/2″ | In distribution |
| 3722036 | 6-1/2″ | In distribution |
| 3722088 | 6-1/2″ | In distribution |
| 3722082 | Length 2 mm | In distribution |
| 3722040 | 6-1/2″ | In distribution |
| 3722008 | 6-1/4″ | In distribution |
| 3722112 | In distribution | |
| 3722100 | In distribution | |
| 3722023 | Length 6 in | In distribution |
| 3722047 | Width 1.25 mm | In distribution |
| 3722027 | Width 4 mm | In distribution |
| 3722159 | In distribution | |
| 3722046 | Width 1.5 mm | In distribution |
| 3724305 | Width 1.5 mm | In distribution |
| 3724281 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 52 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 48 |
| MicroFrance® | Integra Microfrance SAS | 43 |
| V. Mueller | Steris Corporation | 36 |
| Jedmed | Jedmed Instrument Company | 30 |
| HNM Medical | HNM Stainless, LLC. | 29 |
| Inka | The Trustee for Kaiser Family Trust | 23 |
| Ambler Surgical | Ambler Surgical, LLC | 22 |
| Aesculap | Aesculap AG | 21 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 18 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 15 |
| Sklar | Sklar Corporation | 14 |
Showing 12 of 41. All products under Knife, 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.