Rongeur
Beyer Rongeur Single Action
1manufacturer
6catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
Record
| Listed by | Katena Products, Inc., United States |
|---|---|
| FDA product code | HNG |
| Device type | Rongeur, Lachrymal Sac |
| 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 | 2022-12-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Sizes | Width 3 to 4.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K7-1800 | Width 3 mm | In distribution |
| K7-1801 | Width 3.5 mm | In distribution |
| K7-1803 | Size 3 | In distribution |
| K7-1805 | In distribution | |
| K7-1810 | In distribution | |
| K7-1802 | Size 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stephens Instruments | Krishna Imports Inc | 5 |
| Rumex | Rumex International Co. | 2 |
| Intacs Pocketing Hook | Addition Technology, Inc. | 1 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 1 |
| Belz Lacrimal Sac Rongeur | Bausch & Lomb Incorporated | 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.