Novo Surgical Inc.
novo universal trephine handle
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (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 |
Record
| Listed by | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | HRH |
| Device type | Trephine, Manual, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-11-14 |
| Record revised | 2024-04-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OP7151-11 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Coronet | Network Medical Products, Ltd. | 203 |
| Ambler Surgical | Ambler Surgical, LLC | 106 |
| Surgistar | Surgistar, Inc. | 94 |
| Corneal Trephine | Katena Products, Inc. | 72 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 53 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 50 |
| Coronet | CorneaGen | 44 |
| Novo Surgical | Novo Surgical, Inc. | 30 |
| Eyetec | Network Medical Products, Ltd. | 28 |
| Surtex | Surtex Instruments Ltd | 27 |
| Beaver | Beaver-Visitec International, Ltd | 26 |
| Corneal Trephine Blade | Sontec Instruments, Inc. | 25 |
Showing 12 of 98. All products under Trephine, Manual, Ophthalmic
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.