Lacrimal Probe
Miyake Lacrimal PROBE.55 AND.6MM
6manufacturers in China registered for this device type
20catalogue 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 | Katena Products, Inc., United States |
|---|---|
| FDA product code | HNL |
| Device type | Probe, Lachrymal |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-14 |
| Record revised | 2023-02-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Sizes | Lumen/inner diameter 0.45 to 0.9 mm; length 12 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K7-2483 | Lumen/Inner Diameter 0.55 mm | In distribution |
| K7-2550 | Size 5 | In distribution |
| K7-2489 | Lumen/Inner Diameter 0.9 mm | In distribution |
| K7-2560 | Size 7 | In distribution |
| K7-2610 | In distribution | |
| K7-2600 | In distribution | |
| K7-2630 | In distribution | |
| K7-2510 | Size 0000 | In distribution |
| K7-2487 | Lumen/Inner Diameter 0.8 mm | In distribution |
| K7-2530 | Size1 | In distribution |
| K7-2485 | Lumen/Inner Diameter 0.7 mm | In distribution |
| K7-2500 | In distribution | |
| K7-2602 | Length 12 in | In distribution |
| K7-2480 | In distribution | |
| K7-2900 | In distribution | |
| K7-2520 | Size 0000 | In distribution |
| K7-2623 | In distribution | |
| K7-2620 | In distribution | |
| K7-2540 | Size 3 | In distribution |
| K7-2481 | Lumen/Inner Diameter 0.45 mm | In distribution |
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.