Avalign
Paparella Incudostapedial Knife, #4,
2manufacturers in China registered for this device type
30catalogue 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 | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | KTG |
| Device type | Knife, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-28 |
| Record revised | 2023-07-06 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VM104-1852 | In distribution | |
| VM101-4412 | In distribution | |
| VM104-1836 | In distribution | |
| VM101-4415 | In distribution | |
| VM101-4545 | In distribution | |
| VM104-6691 | In distribution | |
| VM104-1011 | In distribution | |
| VM101-4544 | In distribution | |
| VM101-4513 | In distribution | |
| VM101-4416 | In distribution | |
| VM101-4418 | In distribution | |
| VM104-6693 | In distribution | |
| VM101-4034 | In distribution | |
| VM101-4714 | In distribution | |
| VM101-3038 | In distribution | |
| VM104-1846 | In distribution | |
| VM101-4512 | In distribution | |
| VM101-4627 | In distribution | |
| VM104-1016 | In distribution | |
| VM101-3043 | In distribution | |
| VM104-1857 | In distribution | |
| VM101-4617 | In distribution | |
| VM101-4419 | In distribution | |
| VM101-4417 | In distribution | |
| VM101-4413 | In distribution | |
| VM101-4123 | In distribution | |
| VM101-3016 | In distribution | |
| VM101-3041 | In distribution | |
| VM101-4414 | In distribution | |
| VM101-3014 | 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 |
| 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.