Bausch + Lomb
NDL Utility Rosen Type House
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Jiangxi.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiujiang Meite Jewelry Co..Ltd. | Jiujiang | Jiangxi | Manufacturer | 3 |
| Nanchang Firstomato Medical Devices Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 1 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | JYS |
| Device type | Perforator, Ear-Lobe |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-08-15 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N1705 02D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Richline Group, Inc. d/b/a Inverness | Richline Group, Inc. | 7 |
| Fisch footplate perforator | Spiggle & Theis Medizintechnik Gmbh | 6 |
| Lucae tympanum perforator | Spiggle & Theis Medizintechnik Gmbh | 1 |
| Richline Greoup, Inc. d/b/a Inverness | Richline Group, Inc. | 1 |
| Politzer tympanum perforator | Spiggle & Theis Medizintechnik Gmbh | 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.