Bausch + Lomb
Elevator Louisville Type Large
3manufacturers in China registered for this device type
29catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), 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 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | KAD |
| Device type | Elevator, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-11-20 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N2351 | In distribution | |
| N5141 | In distribution | |
| N2358 | In distribution | |
| E4595 | In distribution | |
| SP7-35672B | In distribution | |
| N1124 | In distribution | |
| N1132 | In distribution | |
| SP7-53449 | In distribution | |
| SP7-71329 | In distribution | |
| N1138 | In distribution | |
| SP7-64763 | In distribution | |
| N5140 | In distribution | |
| N2340 | In distribution | |
| SP7-35672 | In distribution | |
| N2348 | In distribution | |
| N4655 | In distribution | |
| N4610 | In distribution | |
| N4660 | In distribution | |
| SP7-55579 | In distribution | |
| N2352 | In distribution | |
| N1705 D | In distribution | |
| N4640 | In distribution | |
| SP7-35341 | In distribution | |
| N2346 | In distribution | |
| N2349 | In distribution | |
| N4657 | In distribution | |
| SP7-35672A | In distribution | |
| N2341 | In distribution | |
| N2362 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 105 |
| MicroFrance® | Integra Microfrance SAS | 75 |
| Boss Instruments | Boss Instruments, Ltd. | 66 |
| V. Mueller | Steris Corporation | 60 |
| Novo Surgical | Novo Surgical, Inc. | 54 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 49 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 49 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 45 |
| Millennium | Avalign Technologies, Inc. | 43 |
| Pilling | Teleflex Medical LLC | 43 |
| Avalign | Avalign Technologies, Inc. | 41 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 35 |
Showing 12 of 111. All products under Elevator, 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.