Bausch + Lomb
Retr Schuknect Weitlanr 5" LNG
3manufacturers in China registered for this device type
39catalogue 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 Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | KAL |
| Device type | Retractor, 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 | 2024-11-21 |
| Record revised | 2025-04-22 (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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N4835 | In distribution | |
| N4870 | In distribution | |
| N3322 | In distribution | |
| N3324 | In distribution | |
| N3323 | In distribution | |
| N4784 | In distribution | |
| X0300 | In distribution | |
| N4847 | In distribution | |
| N4772 | In distribution | |
| N3321 | In distribution | |
| N4770 | In distribution | |
| N6225 | In distribution | |
| N1268 | In distribution | |
| X0302 | In distribution | |
| N1705 71 | In distribution | |
| N4830 | In distribution | |
| N1692 31 | In distribution | |
| NLS3480 | In distribution | |
| N1692 30 | In distribution | |
| N4750 | In distribution | |
| SP7-70377 | In distribution | |
| N4880 | In distribution | |
| N1685 S22 | In distribution | |
| N5152 | In distribution | |
| X0298 | In distribution | |
| N1820 | In distribution | |
| N4285 | In distribution | |
| N3553 | In distribution | |
| N6220 | In distribution | |
| N1822 | In distribution | |
| N1685 P60R | In distribution | |
| N1685 P60L | In distribution | |
| N4780 | In distribution | |
| N4825 | In distribution | |
| N4843 | In distribution | |
| N4841 | In distribution | |
| N4882 | In distribution | |
| SP7-66619 | In distribution | |
| N5176 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Steris Corporation | 138 |
| Ambler Surgical | Ambler Surgical, LLC | 105 |
| Pilling | Teleflex Medical LLC | 90 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 89 |
| Boss Instruments | Boss Instruments, Ltd. | 61 |
| Avalign | Avalign Technologies, Inc. | 54 |
| Fentex | Fentex medical GmbH | 54 |
| Novo Surgical | Novo Surgical, Inc. | 52 |
| Millennium | Avalign Technologies, Inc. | 47 |
| Aesculap | Aesculap AG | 46 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 43 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 42 |
Showing 12 of 80. All products under Retractor, 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.