Bausch + Lomb
HDL F/E828 Spud Needle & Gouge
4manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | HNA |
| Device type | Spud, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-11-21 |
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 |
|---|---|---|
| E0828 B | In distribution | |
| E0828 C | In distribution | |
| E0828 A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Jarit® | Integra LifeSciences Production Corporation | 14 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 13 |
| Ambler Surgical | Ambler Surgical, LLC | 12 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 12 |
| Stephens Instruments | Krishna Imports Inc | 7 |
| Spud, Ophthalmic | Geuder Aktiengesellschaft | 5 |
| Spud | Katena Products, Inc. | 5 |
| Phaco Chopper | Sontec Instruments, Inc. | 3 |
| Pilling | Teleflex Medical LLC | 3 |
| Nagahara Chopper | Sontec Instruments, Inc. | 3 |
| Intracapular Manipulating Wand | Sontec Instruments, Inc. | 3 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 3 |
Showing 12 of 59. All products under Spud, Ophthalmic
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.