Stephens Instruments
Ruler, Stainless Steel, 0.5mm Marking
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Shanghai Lucidarx Optical LLC | Shanghai | Shanghai | Contract manufacturer | 9 |
Record
| Listed by | Krishna Imports Inc |
|---|---|
| FDA product code | HLE |
| Device type | Ruler, Nearpoint (Punctometer) |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1790 |
| Premarket notification | Exempt |
| Record published | 2020-09-22 |
| Record revised | 2024-09-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Storage | Special storage condition: Room Temperature |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S4-1490 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ruler, Nearpoint (Punctometer) | Geuder Aktiengesellschaft | 2 |
| Clement Clarke Ophthalmic | Haag-Streit UK Ltd. | 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.