Ambler Surgical
McCabe flap knife dissector, 7 1/4'', double-ended, straight shafts, angled 25 degrees and 45 degrees, 2.0mm wide x 3.0mm long blades, flat handle
2manufacturers in China registered for this device type
87catalogue 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 | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | KTG |
| Device type | Knife, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-07 |
| Record revised | 2021-06-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| House sickle ”Number One” knife | In distribution | |
| House-Sheehy ”Small Weapon” knife curette | In distribution | |
| Shea incision knife | In distribution | |
| Shambaugh-Derlacki Harrison knife | In distribution | |
| Paparella drum elevator knife | In distribution | |
| House incudostapedial joint knife | In distribution | |
| Paparella canal knife | In distribution | |
| Tabb myringoplasty knife | In distribution | |
| Paparella sickle knife | In distribution | |
| Jako micro laryngeal knife | In distribution | |
| Paparella canal knife | In distribution | |
| Paparella sickle knife | In distribution | |
| Ear knife complete set | In distribution | |
| Ballenger swivel knife | In distribution | |
| McCabe Culbertson canal knife | In distribution | |
| Schuknecht sickle knife | In distribution | |
| Paparella canal knife | In distribution | |
| Freer septum knife | In distribution | |
| Royce ear knife | In distribution | |
| Ear knife set handle only | In distribution | |
| Hough tendon knife | In distribution | |
| Tabb myringoplasty knife | In distribution | |
| Jordan stapedectomy knife | In distribution | |
| Silverstein knife | In distribution | |
| Austin sickle knife | In distribution | |
| Tabb pick knife | In distribution | |
| McCabe flap knife | In distribution | |
| Paparella canal knife | In distribution | |
| Tabb myringoplasty knife | In distribution | |
| House knife | In distribution | |
| House knife | In distribution | |
| Sickle knife | In distribution | |
| McCabe flap knife dissector | In distribution | |
| Guilford-Wright sickle knife | In distribution | |
| Royce ear knife | In distribution | |
| Jako micro laryngeal knife | In distribution | |
| Ballenger swivel knife | In distribution | |
| House lancet ”Number Two” knife | In distribution | |
| Royce ear knife | In distribution | |
| Myringotomy knife | In distribution | |
| Hough incision knife | In distribution | |
| Shambaugh-Derlacki Ghandi knife | In distribution | |
| House tympanoplasty knife | In distribution | |
| Freer septum ”E” knife | In distribution | |
| Ear knife set replacement blade only | In distribution | |
| McCabe canal knife | In distribution | |
| Ballenger swivel knife | In distribution | |
| Sickle knife | In distribution | |
| Hough ”Whirly Bird” knife | In distribution | |
| Silverstein knife | In distribution | |
| Paparella canal knife | In distribution | |
| Politzer ear knife | In distribution | |
| Hough ”Whirly Bird” knife | In distribution | |
| Rosen cartilage knife | In distribution | |
| Derlacki capsule knife | In distribution | |
| Schuknecht roller knife | In distribution | |
| Watson skin graft knife | In distribution | |
| McGee oval window rasp | In distribution | |
| Ballenger swivel knife | In distribution | |
| Tabb flap knife | In distribution | |
| Ballenger swivel knife | In distribution | |
| Shambaugh-Derlacki Harrison knife | In distribution | |
| Hough ”Whirly Bird” knife | In distribution | |
| Watson skin graft knife replacement blade | In distribution | |
| Schuknecht roller knife | In distribution | |
| House myringotomy knife | In distribution | |
| Rosen incision knife | In distribution | |
| Freer septum ”D” knife | In distribution | |
| Ballenger swivel knife | In distribution | |
| Sickle knife | In distribution | |
| Myringotomy knife | In distribution | |
| McGee oval window rasp | In distribution | |
| Austin dissection knife | In distribution | |
| Royce ear knife | In distribution | |
| Baron ear knife | In distribution | |
| House incudostapedial joint knife | In distribution | |
| Derlacki capsule knife | In distribution | |
| Paparella sickle knife | In distribution | |
| Guilford-Wright flap knife | In distribution | |
| House-Sheehy ”Large Weapon” knife curette | In distribution | |
| Paparella incudostapedial joint knife | In distribution | |
| Hough ”Small Weapon” knife | In distribution | |
| Jordan canal elevator | In distribution | |
| House myringotomy blade | In distribution | |
| McCabe canal knife | In distribution | |
| Hough ”Whirly Bird” knife | In distribution | |
| Sickle knife | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Boss Instruments | Boss Instruments, Ltd. | 91 |
| 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 |
| BR Surgical, LLC | BR Surgical LLC | 21 |
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.