Elmed
Bowman lacrimal probes. Double-ended. Straight tip. Silver. Overall length 5-1/2in (14cm). Sizes 0000-000.
6manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (1), Shandong (1). 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 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
Record
| Listed by | Elmed, Inc., United States |
|---|---|
| FDA product code | HNL |
| Device type | Probe, Lachrymal |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-10 |
| Record revised | 2024-11-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date |
| Distribution end date | 2024-10-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EL-OP7020-012 | In distribution | |
| EL-OP7020-078 | In distribution | |
| EL-OP7020-700 | In distribution | |
| EL-OP7020-034 | In distribution | |
| EL-OP7020-300 | In distribution | |
| 43614-78 | In distribution | |
| 43613-00 | In distribution | |
| EL-OP7020-056 | In distribution | |
| 43614-12 | In distribution | |
| 43614-34 | In distribution | |
| 43614-00 | In distribution | |
| 43614-56 | In distribution | |
| 43613-00 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Probe | KLS-Martin L.P. | 56 |
| Ambler Surgical | Ambler Surgical, LLC | 36 |
| Millennium | Avalign Technologies, Inc. | 35 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 33 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 32 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 24 |
| Walcott Rx Products | Walcott Rx Product Inc | 24 |
| BR Surgical, LLC | BR Surgical LLC | 22 |
| Probe, Lachrymal | Geuder Aktiengesellschaft | 21 |
| Boss Instruments | Boss Instruments, Ltd. | 21 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 21 |
| Bowman Lacrimal Probe | Sontec Instruments, Inc. | 21 |
Showing 12 of 75. All products under Probe, Lachrymal
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.