Integra® Miltex®
Integra® Miltex® Fisher Tonsil Knife, 8-1/4", Curved Blade, Serrated on Top
2manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | KBQ |
| Device type | Knife, Tonsil |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-12 |
| Record revised | 2023-04-27 (version 6) |
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 |
|---|---|---|
| 22-802 | 8-1/4″ | In distribution |
| 22-808 | 8-1/4″ | In distribution |
| MH22-808 | 8-1/4″ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 8 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 6 |
| Millennium | Avalign Technologies, Inc. | 4 |
| Pilling | Teleflex Medical LLC | 3 |
| Aesculap | Aesculap AG | 3 |
| Avalign | Avalign Technologies, Inc. | 3 |
| Novo Surgical | Novo Surgical, Inc. | 3 |
| V. Mueller | Carefusion 2200, Inc. | 3 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 2 |
| V. Mueller | Steris Corporation | 2 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 2 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 2 |
Showing 12 of 24. All products under Knife, Tonsil
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.