Bausch + Lomb
Needle Fascia Iliff - Wright
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | FHR |
| Device type | Needle, Gastro-Urology |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-08-18 |
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 |
|---|---|---|
| E2490 | In distribution | |
| E2488 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Carefusion 2200, Inc. | 7 |
| V. Mueller | Steris Corporation | 3 |
| Cook | Cook Incorporated | 2 |
| Avalign | Avalign Technologies, Inc. | 1 |
| Millennium | Avalign Technologies, Inc. | 1 |
| Pilling | Teleflex Medical LLC | 1 |
| Rigid Needle 21 GA x 0.5″ (0,8 x 13 mm) | Merz North America, Inc. | 1 |
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.