GEN2
Sinus Sickle Knife, Sharp Adult, 7-1/2" (19CM)
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 | Surgix Medical LLC, United States |
|---|---|
| FDA product code | KTG |
| Device type | Knife, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-17 |
| Record revised | 2022-12-12 (version 2) |
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 |
| Sizes | Length 5.25 to 7.5 in; length 160 to 190 mm; angle 45 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G2E901134 | In distribution | |
| G2E900935 | Length 5.25 in | In distribution |
| G2E901156 | Length 6.25 in | In distribution |
| G2E900957 | Length 190 mm | In distribution |
| G2E901345 | Length 6.5 in | In distribution |
| G2E901133 | In distribution | |
| G2E900957 | Length 190 mm | In distribution |
| G2E901130 | In distribution | |
| G2E2624 | Length 7.5 in | In distribution |
| G2E901132 | Length 7.25 in | In distribution |
| G2O917144 | Length 160 mm | In distribution |
| G2E901131 | Length 6.5 in | In distribution |
| G2E901163 | Angle 45 ° | In distribution |
| G2E901147 | Length 6.5 in | In distribution |
| G2E17506 | Tip Length 5 mm | In distribution |
| G2E17506 | Tip Length 5 mm | 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.